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

Model Number ASKU

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2019

Event Type  malfunction  

Manufacturer Narrative

The patient's exact age is unknown; however, this was reported to be a pediatric patient.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the prismaflex machine had a black screen and was screeching during treatment.While trying to unload the set a line not clamped alarm occurred.After unsuccessful troubleshooting the treatment was ended without returning the extracorporeal blood to the pediatric patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was not returned therefore, a device analysis could not be completed.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.

• 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: 8543615
• MDR Text Key: 142925446
• Report Number: 9616026-2019-00021
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 05/21/2019

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 Model Number: ASKU
• Device Catalogue Number: 955052
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/30/2019
• Initial Date Manufacturer Received: 03/30/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX SET; PRISMAFLEX SET
• Patient Outcome(s): Other