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

Catalog Number	104176
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2020
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 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.
Additional 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.
Additional 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
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10769772
• Report Number: 9611369-2020-00149
• Device Sequence Number: 4141837
• Product Code: KDI
• UDI-Device Identifier: 07332414048181
• UDI-Public: (01)07332414048181
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 11/27/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/19/2020; 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1