MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 21L; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 104176

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during treatment with a polyflux21l dialyzer, a blood leak at the venous side was observed.The patient was immediately disconnected.Blood loss was reported to be "only a few drops".There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection with the naked eye showed that the product was wet with no issues noted.A leakage test of the dialysate side was performed, and no leaks were observed.A leakage test of the blood side was performed, and no leaks were observed.The reported condition was not verified.The cause of the condition 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.

Manufacturer Narrative

H10: the actual sample was received for evaluation.Visual inspection of the product showed the product was wet.A leak test of the dialysate and blood side was performed and this test showed no leak confirming an internal blood leak and not an external leak as reported.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 21L
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10769772
• MDR Text Key: 214150684
• Report Number: 9611369-2020-00149
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414048181
• UDI-Public: (01)07332414048181
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 104176
• Device Lot Number: 0-6023-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 11/12/2020; 11/27/2020
• Supplement Dates FDA Received: 11/19/2020; 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1