MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM 2400 MAIN MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number	2400M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient received total parenteral nutrition (tpn) compounded by an automated compounding device em 2400 main module compounder.After administration of the tpn, the patient experienced higher than expected blood glucose levels.The patient's blood glucose level was "105 in the morning", a "bag was hung" at 18:00 hours and the patient's blood glucose level was found to be 282 at 21:42 hrs.It was further reported that "the providers opted to run a bag of d10/0.45ns on the compounder and give it to the patient".According to the reporter, the patient's blood glucose started to ¿trend back down¿.The patient was also initiated on ¿claf/vanc¿ antibiotics "to cover for potential infection".No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3 and h6.Additional information for h10: the exactamix black box data as well as the abacus bag label, mixcheck report, and physician¿s order were reviewed.The actual device was not returned to baxter for evaluation.Upon evaluation of the returned information, there is evidence the tube set was in user beyond the recommended 24-hour installation period, resulting in pump calibration errors and bags running overweight.Warnings were generated by the device indicating that the pump was not set up properly and that the ingredients had been hung beyond 24 hours.Furthermore, there is indication that upon changing the tube set and completing the setup wizard, the pump no longer received calibration errors and consistently ran bags within the facility-defined +/-3% of the ordered volume.The data provided shows that the subject bag produced by this compounder, without any environmental or physical interference, should have been acceptable for clinical use.However, the bag was created using an expired tube set.Evaluation of the orders and black box data revealed that the tube set was used beyond the recommended 24-hour-period which, as per product labelling, this has the potential to lead to delivery inaccuracies.To conclude, it is possible that use error of the tube set used with the compounder contributed to delivery inaccuracy of the tpn solution that caused or contributed to increase in blood glucose for the neonate.Since the sample was not returned it cannot be determined if the sample met specifications.As the most likely cause of this problem is considered use error, a label review was performed.The exactamix operator manual, provides the following message, ¿changing the tube set¿: "warning - to maintain delivery accuracy, the tube set must be replaced after it has delivered 150 l of fluid or been installed for 24 hours, whichever comes first".This is sufficient information to avoid this problem.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400 MAIN MODULE
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16437293
• Report Number: 1416980-2023-00667
• Device Sequence Number: 3126978
• Product Code: NEP
• UDI-Device Identifier: 00085412482637
• UDI-Public: (01)00085412482637
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2400M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: D10/0.45 NS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female