Baxter em2400

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Health product recall. Brand s Baxter Healthcare Corporation. Last updated. Summary Product. Medical devices - Performance issue. What to do. Issue Baxter is issuing an urgent medical device correction communication regarding the potential for leaking valves in the Exactamix valve sets. Recall start date: July 18, Additional information Details Original published date: Health product - Medical device - General hospital and personal use. Published by. Health Canada.

Ongoing i. Results should be reported and regularly reviewed in the assessment of trends and other long-term measures of performance [ 1 ]. There is only few literature available reporting accuracy checks as quality assurance measures of ACDs [ 7 , 8 , 9 ].

To our best knowledge there are no studies published regarding routine assessments of accuracy in the delivery of correct amounts of nutrients by the Baxter EM ACD. The method chosen for process monitoring was the chemical analysis of the concentration of each delivered ingredient in the final PN product compounded with this ACD.

We set the same accuracy limits. The EM compounder has 24 ports for compounding admixtures up to 24 ingredients Figure 1. This ACD is a micro and macro compounder for volume delivery starting at 0. A peristaltic pump system delivers the quantities of components using volumetric measurements. An integrated scale gravimetrically verifies the delivered volume by weighing the final product. The individual ingredients are only weighed during the pumping process if they have volumes above mL.

The flow factor is a control parameter which is determined based on parameters like the density, type and volume of a source product. The flow factor is set for each ingredient and adjusts the pumping speed and thereby the correctness of the pumped volume at the predefined port.

To determine the flow factors, the actual delivered volume of each individual ingredient is measured. For the macro ingredients, volumes of mL are pumped 3 times and the average actual pumped volume is calculated based on the weight measured by the device internal scale and the density of the ingredient.

Based on the actual delivered volume compared to the expected volume, a flow factor is determined with the work sheet provided by Baxter. For micro ingredients, a flow factor for each pumping speed is determined. These flow factors are determined by comparing the actual delivered volume to the expected volume of 5 mL and 20 mL for the slower and higher pumping speed, respectively. An external scale must be used to determine these flow factors.

The source container of each ingredient is removed, weighed and reconnected to the EM Then, the EM is programmed to pump 5 mL of each ingredient and 30 mL water necessary to flush the lines.

Afterward, the individual source containers are removed from the EM and weighed again. The difference in mass and the actual delivered volume is calculated.

For the flow factor for the higher pumping speed setting, the measurement is conducted by pumping a volume of 20 mL for each ingredient and 30 mL of water. Once a flow factor is determined, the correctness is verified by pumping each ingredient three more times. If the accuracy limit is exceeded the flow factor has to be re-adjusted and checked again. The flow factors were adjusted according to the training received during the initial installation using the Baxter handbook and provided worksheet.

The worksheet is an excel spread sheet developed by Baxter with the necessary formulas for the calculations. The flow factors were initially set with the Baxter technicians and were scheduled to be re-evaluated every six months based on the recommendation given by the ACD manufacturer.

Three types of PN preparations were planned. Two further test preparations were prepared containing higher test preparation B and lower test preparation C amounts of each ingredient. Each preparation contained glucose, an amino acid solution, sodium chloride, magnesium aspartate and sterile water for injection s. Table 1. Characteristics of the ingredients and source products used for the test preparations.

The batch-specific concentrations of the source products were measured in the external lab and used to calculate the theoretical concentrations of the test preparations prepared with the ACD. The composition of test preparations A, B, C is described in Table 2 and the volume of each ingredient for each test preparation in Table 3.

This was achieved by adjusting the final volume to 60 mL. Special care was taken to control the conditions of the test environment. The product preparation was conducted by an experienced pharmacy technician in an aseptic environment. The pharmacy technicians were trained by Baxter representatives. All of the ingredients and materials were approved for use in Germany.

During each test preparation period, the ACD was equipped with material from the same batches. The compounding occurred with the EM Test preparations A, B, and C were prepared in triplicate on three consecutive days, leading to 9 products per test preparation and 27 products in total.

The products were prepared in the afternoon of the study day and sent overnight to an external contract laboratory Supramol Laboratory, Friedberg, Germany for end product testing. The products arrived at the laboratory the next morning. One sample was withdrawn from each product to determine the concentrations of each ingredient in triplicate.

Analysis was performed within 16—18 hours after product preparation. Supramol Laboratory was chosen due to its experience with the analysis of nutrition formulations and GMP certification by the German health authorities.

Prior to the study, the source ingredients were sent to the Supramol Laboratory and the batch-specific concentrations of the source ingredients were measured. The actual concentrations see Table 1 were used to calculate the concentrations of the ingredients in the test preparations. The test preparations consisted of ingredients which are routinely used in the pharmacy and could be tested with the validated analytical methods in the contract laboratory.

The methods were validated in the contract lab to be appropriate for parenteral nutrition products based on the current Ph. Prior to the measurements the analytical methods were validated by the contract lab. The concentrations of the individual ingredients were determined by a validated HPLC assay N-Acetyl-L-tyrosine, glucose and titration titration with silver nitrate for sodium chloride and titration with EDTA for magnesium aspartate.

The average concentration of each ingredient and pumped volume was calculated based on the 9 test preparations A, B and C each. The ratio of the delivered concentrations to the expected concentrations were calculated as percentage.

Accuracy of pumping was determined as the deviation of the mean of the delivered concentration from the expected concentration for each ingredient in each test preparation in percent according to [ 6 ].

Precision and intermediate precision was determined with the relative standard deviations with the intra-series variance and the sum of the intra- and the inter-series variances, respectively. If the out of specification results were confirmed, the settings of the ACD such as the flow factors pertaining to the ingredient out of specification had to be reevaluated. If a flow factor had to be reset see paragraph Flow Factor Settings above , additional test preparations had to be compounded.

This was the case for the NaCl solution as source ingredient. Additional test preparations were scheduled. Test preparation D contained 3 mL of NaCl 5.

To obtain comparable results, the same concentration as in test preparation A and B were chosen. All the test preparations fulfilled this requirement according to the internal gravimetric verification of the EM The ratio of the delivered concentrations to the expected concentrations as percentage for each ingredient in each test preparation A-C is shown in Figure 2.

Percentage of the delivered concentration compared to the expected concentration of each ingredient. The accuracy, precision and intermediate precision for the concentrations of the four ingredients pumped with the EM are shown in Table 4 for test preparation A, B, and C. However, the intermediate precision was 0.

The intermediate precision amounted to 2. The out of specification sodium concentrations were confirmed using flame atomic spectroscopy Biochem GmbH, Karlsruhe, Germany. Therefore, we assumed a technical problem specific to the port in the valve assembly of the EM which delivers NaCl. After resetting the flow factor for the NaCl solution, the delivery revealed acceptable accuracy. The intermediate precision for test preparation D amounted to 0. Intermediate precision for test preparation E amounted to 2.

PN mixtures are often aseptically prepared by hospital pharmacies using automated compounding devices like the Baxter EM ACDs like the Baxter EM are qualified by the manufacturer by conducting a design qualification DQ which documents that the design and purpose of the device are suitable. When the device is installed in the pharmacy department installation qualification IQ and operational qualification OQ are conducted. Ongoing quality assurance measures for assessing the performance of the compounder in daily practice are to be specified and implemented in the pharmacy department.

Process monitoring for proper function, accuracy and precision are compulsory to ensure the correct delivery of ingredients when compounding PN with an ACD [ 6 ]. We designed three different test PN mixtures to be prepared on three consecutive days and planned a quantitative analysis of the ingredients as accuracy monitoring for the Baxter EM Test preparations were designed to simulate typical PN preparations while also covering upper and lower operation limits of the Baxter EM Using a glucose solution with a lower concentration as source ingredient would lead to volumes which would be too high for the needs of some of the extremely premature neonates.

At very low volumes the accuracy of delivery of such viscous solutions can be affected. The decreased accuracy in test preparation C can be due to the high viscosity of the ingredient. Weight-based checks confirmed the improved accuracy. In general, increased care should be taken when ingredients with high viscosities are used for compounding. This information about delivery speed adjustments for other ingredients with high viscosities should be made available in the documents provided by the manufacturer and taken into consideration during installation.

Nevertheless, the ingredients, except NaCl 5. We were not able to explain the distinct deviation of the NaCl concentration in the test preparations A, B and C or the extremely high intermediate precision of the NaCl concentration in test preparation C.

The variation in NaCl for test preparation C does not correlate with the delivery of small volumes taking the accuracy and intermediate precision of the other ingredients such as MgAsp into consideration. Therefore, an issue which specifically affected the NaCl delivery was expected. The study was scheduled to be conducted with the initial flow factors settings before the next re-evaluation took place.

However, since other possible errors were ruled out it was decided to re-evaluate the flow factors prior. Only the adjustment of the flow factors allowed for NaCl 5. This shows the need for ongoing process monitoring and possibly flow factor adjustments when necessary. In this case only the NaCl port was affected and required adjustments.

Adjustments could, however, be necessary for other ingredients in the future. Therefore, it is necessary to test each ingredient and port used. The ingredients in this study were limited to the validated methods of the external lab. The observed fluctuations prove, however, that it is necessary to test every ingredient especially critical ingredients such as potassium chloride [ 12 ].

It is known, that variations between source product batches and changes over time can lead to differences in the delivery of the ingredients. Consequently, Baxter recommends re-evaluating the flow factors at least every six months even when the ingredients remain the same.

Moreover, based on the study results it is highly recommended to conduct ongoing process monitoring for the delivery of each ingredient or at least the critical ones like potassium regularly [ 12 ]. This is especially true when preparation is done on a patient individual basis and not batch-wise. In the latter case the amounts of the ingredients are usually analyzed during end-product testing before releasing the batch.

In the case of patient-individual PN compounding a dummy product containing a defined amount of each ingredient could be prepared. However, chemical analysis of each ingredient is not feasible in daily practice as process monitoring for the ACD, especially when the tests have to be assigned to an external lab. This agrees with a past accuracy study of older ACD models which also discussed the limitations of this method [ 8 ].

There is a need for a more efficient method for process monitoring to be implemented and conducted on a preassigned regular basis. Planning of the test preparations in this study was originally intended to simulate typical PN products for neonates and to deliver typical amounts of ingredients with the ACD.

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Baxter em2400	She received financial support through B. Successful exploitation of these vulnerabilities could result in unauthorized access to sensitive data, baxter em2400 of system configuration, alteration of system resources, and baxter em2400 to system availability. Ongoing quality assurance measures for congratulate, cognizant nda apologise the performance of the compounder in daily practice are to be specified and implemented in the pharmacy department. IngC. Driscoll DF. This leak would baaxter most noticeable when the Exactamix compounder is pumping and moving fluid through the common fluid pathway.
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Baxter em2400	If you baxter em2400 to baxter em2400 a follow-up reply, article source include your name and e-mail address. Solutions to such issues obtained during quality performance measurements should be made available by the ACD manufacturer to all customers in the official documents of the ACD. Accuracy of parenteral nutrition solutions compounded with automated systems and by hand. The product preparation was conducted by an experienced pharmacy technician in an aseptic environment. The decreased accuracy in test preparation C can be due to the high viscosity of the ingredient. Nevertheless, the ingredients, except NaCl 5. All of the ingredients and materials were approved baxter em2400 use in Germany.
Baxter em2400	Driscoll Medicine. Medical devices - Performance issue. We have detected that you are using Internet Explorer baxtrr visit this website. In this case only the Here port was affected and required adjustments. An external scale must be used to determine these flow factors. The ratio of the delivered concentrations to the expected concentrations were calculated as baxter em2400.
Cognizant technology solutions gmbh	Save emblemhealth select care Library Save. View 1 excerpt, references results. There is a need for a more efficient method for process monitoring to be implemented and conducted on a preassigned regular basis. Ensure ExactaMix Compounder passwords are kept confidential. CVE has been assigned to this vulnerability. Tribble Chemistry, Medicine. Quality assurance measures are to be implemented in baxter em2400 pharmacy department in order to ensure the accurate delivery of the PN additives [ 1 ].

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