MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VALVE SET, EM2400; SET, I.V. FLUID TRANSFER

Catalog Number H938724

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

Patient Problem Cardiac Arrest (1762)

Event Date 07/05/2022

Event Type  Injury  

Event Description

It was reported a preterm patient experienced hyperkaliemia and subsequently "coded" following administration of total parenteral nutrition (tpn) with an em2400 valve set in use with a compounding device.It was further reported the patient required resuscitation.The cause of and treatment for the hyperkalemia were not reported.The source of potassium (k) came from k phosphate (2 meq/kg/day, total of 0.74 mls).During the compounding process ¿no issues¿ or alerts occurred.According to reporter, the patient was ¿stabilized but still has high levels of potassium¿ (values not reported).Tpn without potassium was resumed.Attempts to obtain the valve set for investigation is on-going.No additional information is available.

Manufacturer Narrative

Age at time of event: 11 days old.Weight: 0.43 kilograms.According to the compounder mixcheck report, and the compounder em2400 black box data were evaluated.Based on this evaluation, the compounder and order entry software operated as intended.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was not returned for evaluation; however, the abacus bag label, compounder mixcheck report, and compounder black box data were submitted and evaluated.Based on this evaluation, the em2400 compounder, the compounder software and the abacus order entry software operated as intended and likely did not contribute to the reported event.Copies of the compounder mixcheck report and abacus bag label were provided by the customer during clinical investigation.An evaluation of the abacus bag label indicates that the only source of k is coming from k phosphate.The total volume ordered for k phosphate was 2 meq/kg/day.An evaluation of the compounder mixcheck report indicates that the ordered ingredients match the abacus bag label.The total compounded volumes of the subject bags are within +/-3% of the ordered volumes.The details section of the report does not indicate any errors that occurred during the compounding of the subject bag.A complete review of the compounder black box data showed no other unusual activity for the production run on the event date.In addition, it appropriately delivered the requested volumes of ingredients for the day¿s production.None of the ingredients within the manual additions list contained k.In summary, there is no evidence that the em2400 compounder, the compounder software, or the abacus order entry software contributed to the patient's hyperkalaemia.The data provided shows that the bags produced by this compounder, without any environmental or physical interference, should have been acceptable for clinical use.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VALVE SET, EM2400
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TIJUANA BAJA; blvd pacifico 10014; parque industrial pacifico; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15176411
• MDR Text Key: 297350359
• Report Number: 1416980-2022-04071
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: H938724
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 09/02/2022; 10/21/2022
• Supplement Dates FDA Received: 09/09/2022; 10/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABACUS BAG.; EM2400 COMPOUNDER.; K PHOSPHATE.
• Patient Outcome(s): Required Intervention