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

Catalog Number	103530
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10952308
• Report Number: 9611369-2020-00180
• Device Sequence Number: 16865150
• Product Code: KDI
• UDI-Device Identifier: 07332414037925
• UDI-Public: (01)07332414037925
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K043342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1