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

Catalog Number 2400M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 310170072
• Report Number: 1416980-2023-00667
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412482637
• UDI-Public: (01)00085412482637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2400M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: D10/0.45 NS
• Patient Outcome(s): Required Intervention
• Patient Sex: Female