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

Catalog Number 113082

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. A review of the event history log was performed and revealed that the device had presented a pbp scale alarm. Functional testing and electrical safety testing were performed with no issues noted. Simulated use testing was performed, and the device was found to correctly present an alarm when the pbp bag was moved. The reported alarm was identified during evaluation; however, the device was found to be operating per specification. 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

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

Event Description

This is a report of a patient who was prescribed continuous renal replacement therapy (crrt) using a prismaflex machine. While the patient was connected to the device the machine was moved and the monitor subsequently displayed an unspecified error alarm related to a ¿scale issue. ¿ it was reported that following the error message, the device operator tried to put the machine in patient mode but the device was no longer functional. The patient did not receive the treatment and reportedly died later the same day (cause of death not reported). No additional information is available.

• 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
• Manufacturer (Section G): BAXTER HEALTHCARE - LUND MONITORS; magistratsvagen 16; lund skane lan 22643 ; SW 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6826807
• MDR Text Key: 105926332
• Report Number: 9616026-2017-00058
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K110823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 113082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/29/2017 Patient Sequence Number: 1