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 Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 12/16/2019

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 (crrt), the patient ¿coded¿ and 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.At the time of this report, no further details were provided regarding patient treatment or medical interventions.No additional information is available.

Manufacturer Narrative

The device was evaluated onsite by a qualified baxter technician.A service history review revealed that no repetitive similar failure occurred, which indicates that any parts replaced during servicing did not cause or contribute to the reported event.An inspection of the machine did not identify any abnormalities that could have contributed to the reported condition.The device was inspected and returned to use.The baxter device is no longer a suspect in the reported death.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: 9569459
• MDR Text Key: 174314239
• Report Number: 9616026-2019-00065
• 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
• Report Date: 02/21/2020

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: 115269
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death