MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 106697

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2020

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 treatment with one unit of prismaflex m100 set, the effluent pouch close to the connection was observed to be torn.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; deerfield IL
• MDR Report Key: 10071380
• MDR Text Key: 195716631
• Report Number: 8010182-2020-00045
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414064556
• UDI-Public: (01)07332414064556
• Combination Product (y/n): N
• PMA/PMN Number: K041005
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 106697
• Device Lot Number: 19G0202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1