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

Catalog Number 107493

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

Patient Problem Death (1802)

Event Date 12/23/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that during treatment with continuous veno-venous hemofiltration using a prismaflex control unit, the patient passed away.The event occurred 15 after starting therapy.There was no report of a medical intervention associated with this event.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

Upon follow up it was reported the patient was 13 minutes into the continuous veno-venous hemofiltration treatment when the patient experienced hypotension with a systolic blood pressure of ¿46-48¿.The device was evaluated on site.A prismaflex verification checklist and complete machine checkout was performed.No deviations were found and the machine was found to be working within specifications.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.As no malfunction of the prismaflex machine was identified and there is no indication that the device caused or contributed to the event, the prismaflex machine is no longer considered suspect product in this 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 - LUND MONITORS; lund skane lan
• MDR Report Key: 8302223
• MDR Text Key: 134907937
• Report Number: 9616026-2019-00003
• Device Sequence Number: 1
• Product Code: KDI
• 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: 02/04/2019,03/19/2019

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: 107493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2019
• Distributor Facility Aware Date: 01/10/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/04/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX SET; PRISMAFLEX SET
• Patient Outcome(s): Death
• Patient Age: 74 YR