MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX; DIALYZER, CAPILLARY, HOLLOW FIBER

Catalog Number	103579
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter postal code- (b)(6).Two (2) devices were received for evaluation.Visual inspection of the actual samples showed the filters to be contaminated with blood.After disinfection of both products, leakage tests of the blood side were performed and leaks were observed in the potting areas.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was determined to be related to manufacturing in that a short fiber in both products resulted in a bubble at the level of the support ring, which allowed the leaks.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) internal blood leaks were observed from two (2) polyflux 170 h dialyzers during hemodialysis therapy.The blood was not returned to the patient.There was no report of medical intervention associated with this event.No additional information is available.

• Brand Name: POLYFLUX
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; holger - crafoord - strasse 26; hechingen D-723 79; GM D-72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19469509
• Report Number: 9611369-2024-00098
• Device Sequence Number: 11613990
• Product Code: FJI
• UDI-Device Identifier: 07332414037932
• UDI-Public: (01)07332414037932
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K043342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: 09/30/2026
• Device Catalogue Number: 103579
• Device Lot Number: 3-4626-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown