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

Catalog Number 106697

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

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 that an external fluid leak was observed from a small crack in the lower part of a prismaflex m100 set.No alarm was generated.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was not received for evaluation however a drawing of the set was provided to indicate the location of the crack.The crack was located on the access blood header of the filter.The reported condition was verified.The probable cause was identified to be due to a shock during transport or storage.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 CORPORATION; deerfield IL
• MDR Report Key: 11991153
• MDR Text Key: 255934857
• Report Number: 8010182-2021-00195
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414064556
• UDI-Public: (01)07332414064556
• Combination Product (y/n): Y
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Catalogue Number: 106697
• Device Lot Number: 19H2401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1