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 07/14/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported an unknown alarm was generated from a prismaflex control unit at an unspecified time during treatment.The cause of the alarm was not reported.It was reported the patient was connected to the control unit and passed away.The cause of death was not reported.It was not reported if the patient was hospitalized prior to death.It was not reported if an autopsy was performed.It was unknown if the patient was being treated with the prismaflex unit at the time of death.No additional information is available.

Manufacturer Narrative

Cec re-opened because it was identified that the machine was inspected on-site.The device was inspected on site by a qualified baxter technician.The technician tested the return clamp and it performed correctly.The technician measured the voltage on return clamp and the reading was within correct range.A successful prime-test was performed.The technician ran a 15 minute treatment with creating air in blood alarms and clearing the alarms.The return clamp worked correctly while creating and clearing air blood alarms.It was determined that the involved prismaflex machine did not malfunction.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not received for evaluation.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.

Manufacturer Narrative

Correction: removal of information in section f related to importer: the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).

• 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: 8883753
• MDR Text Key: 153982787
• Report Number: 9616026-2019-00045
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/12/2019,12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/12/2019
• Distributor Facility Aware Date: 07/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2019
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death