MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 140H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 112465

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during priming with a polyflux 140h, the product was observed to be broken resulting in a saline leak.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information added to d9, h3, h6 and h10 h10.The device was received for evaluation.The visual inspection by naked eye of the product showed the product wet.A leak test of the dialysate side was performed and a leak was observed due to a crack in the welding seam.The reported condition was verified.The cause is manufacturing related.A nonconformance has been opened to address this issue.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: POLYFLUX 140H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12461296
• MDR Text Key: 271083867
• Report Number: 9611369-2021-00234
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102753
• UDI-Public: (01)07332414102753
• Combination Product (y/n): Y
• 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
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 112465
• Device Lot Number: 1-5811-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1