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 No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that ¿air bubbles came into the return side from the filter.¿ the reporter further stated that the prismaflex machine presented an air in line alarm, but the system did not automatically stop therapy.The therapy was discontinued with blood loss.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A priming test and a simulated use test were performed, and both tests passed successfully with no issues noted.Treatment data was analyzed for the prismaflex control unit.Eleven (11) warning - access extremely negative alarms were issued between 01:19:15 and 01:25:37.This indicates that the vascular access was blocked for about 6 minutes and the operator was required to unblock it.Five (5) malfunction alarm - air detector alarms were issued between 01:26:17 and 01:26:54.When resolving the vascular access issue it is likely that air entered the circuit.That air was then transformed into foam when passing the filter.The foam emptied the deaeration chamber and reached the level of the air detector which caused the prismaflex control unit to issue the malfunction alarm - air detector.The operator choose to continue the treatment after adjusting the level in the deaeration chamber up.This review does not indicate any prismaflex control unit failure or that any air passed the air detector.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: 7407663
• MDR Text Key: 105305189
• Report Number: 9616026-2018-00005
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K110823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1