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

Catalog Number 114870

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the prismaflex machine failed during continuous veno-venous hemodiafiltration (cvvhdf) treatment. The reporter stated that the issue occurred just after the 8. 1 software update. The calcium syringe worked until the first calcium refill, but then no longer moved. The machine did not show any error messages until the user pushed the syringe change button. The calcium was replaced after restarting the prismaflex machine and crrt treatment. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

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. A device history review revealed no issues that could have caused or contributed to the reported issue. The event history log review analysis showed that no calcium was delivered from the change syringe procedure until the treatment was stopped. A condition where the calcium syringe pump became inactive unexpectedly has been verified. The cause of the event was not determined. A nonconformance has been opened to address this issue. 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: 7368494
• MDR Text Key: 103728433
• Report Number: 9616026-2018-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 114870
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No