MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115307

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

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, during patient treatment in the intensive care unit, a prismaflex m150, had the effluent line kink and external blood leakage occurred due to the venous connector being damaged (not further specified).The patient was disconnected and a new set up was used to continue with treatment.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, one photograph of the sample was evaluated.Visual inspection of the photo showed there was a kink on the effluent line and the access line was cracked near the screwed connector.The reported condition was verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition was not determined.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• MDR Report Key: 8445324
• MDR Text Key: 139729379
• Report Number: 8010182-2019-00080
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K080519
• 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: 05/01/2019

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 Expiration Date: 09/01/2020
• Device Catalogue Number: 115307
• Device Lot Number: 18I1405
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1