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

Catalog Number 115269

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

Patient Problem Death (1802)

Event Date 03/04/2020

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, a patient passed away while connected to a prismaflex control unit.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

The actual device was inspected on-site by a qualified baxter technician and no issues were identified.A full technical check of the device was performed and the device was found to meet manufacturer's specifications.The machine was then calibrated and returned to clinical service.A device history review revealed no complaints associated with the device in the previous 24 months.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to f tab: importer/reporter number.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: 9889236
• MDR Text Key: 185248647
• Report Number: 9616026-2020-00012
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414117702
• UDI-Public: (01)07332414117702
• Combination Product (y/n): N
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2020,05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115269
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2020
• Distributor Facility Aware Date: 03/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2020
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death