MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955542

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

Patient Problem Death (1802)

Event Date 06/11/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that during continuous renal replacement therapy with a prismaflex control unit, the patient passed away while connected to the machine.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

H10: the actual device was inspected on-site by a qualified baxter technician and no issues were identified.A full calibration and functional test of the device was performed and the device was found to meet manufacturer's specifications.The reported condition was not verified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10236307
• MDR Text Key: 197673582
• Report Number: 9616026-2020-00017
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124236
• UDI-Public: (01)07332414124236
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/06/2020,08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2020
• Distributor Facility Aware Date: 06/11/2020
• Event Location: Other
• Date Report to Manufacturer: 07/06/2020
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death