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

Catalog Number 103530

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that one hour after starting treatment with a polyflux 140h dialyzer, an external fluid leakage was observed from the arterial end of the dialyzer.It was reported the filter connectors were ¿adjusted¿ and well connected, however, the leakage continued.Total restitution of blood volume to the patient was performed and no blood leak was observed.Treatment was ended.The dialyzer was changed with another polyflux 140h and therapy was continued with no issues noted.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Corrected information added to d4: product lot number changed from 9-5708-h-01 to 8-5720-h-01.H10: the actual device was not returned for evaluation, however a video was provided.Visual inspection of the provided video showed an external leakage (water droplets) on the bottom header cap during treatment.The reported condition was verified.Based on past investigations, the most likely failure is a defective welding seam.Due to the absence of an actual sample, the cause of the reported problem could not be determined.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: 10952308
• MDR Text Key: 227026045
• Report Number: 9611369-2020-00180
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414037925
• UDI-Public: (01)07332414037925
• Combination Product (y/n): Y
• PMA/PMN Number: K043342
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 103530
• Device Lot Number: 8-5720-H-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1