MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE; SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA

Catalog Number 107144

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

Patient Problem Injury (2348)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during therapeutic plasma exchange (tpe) treatment using a prismaflex tpe 2000 set, the patient experienced hyperkalemia.It was reported the patient¿s potassium concentration was ¿raised from 6.0 mmol/l and then increased to 8.3 mmol/l¿ (at the end of the treatment).It was reported that potassium was not added to any of the products or solutions during treatment.No patient symptoms were reported.It was reported the patient was transferred to the intensive care unit to be monitored and was ¿provided with iec drug¿ (no further details).At the time of this report, the patient outcome was reported as ¿the patient is not presenting with hyperkalemia¿.No additional information is available.

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the actual device was not available; however, two companion samples were received for evaluation.Product master tests were performed on the companion samples and the reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.

• Brand Name: PRISMAFLEX TPE
• Type of Device: SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9653106
• MDR Text Key: 177267796
• Report Number: 8010182-2020-00006
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• PMA/PMN Number: P830063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

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: 107144
• Device Lot Number: 19D2601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR