MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC 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	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information h6, h11.H11: the actual device was not available; however, 15 companion samples were returned for evaluation.Visual inspection of the samples showed the products in their original packaging.Functional leak testing of the dialyzer blood side was performed, and a leak was observed in two (2) of the 15 samples.A lengthwise crack was noted in a fiber in each of the two failed samples, which allowed the leakage.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 fiber defect was determined to be related to the manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a blood leak was observed during hemodialysis therapy from unspecified locations of three (3) polyflux 170 dialyzers.The devices were used for one (1) patient, "with the same result".The volume of blood loss or whether blood was returned was not known.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): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - HECHINGEN BADEN DIALYZER; holger - crafoord - strasse 26; hechingen D-723 79; GM D-72379
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 22541035
• Report Number: 9611369-2025-00098
• Device Sequence Number: 7001131
• Product Code: FJI
• UDI-Device Identifier: 07332414037932
• UDI-Public: (01)07332414037932(10)4-4613-H-01(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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 Catalogue Number: 103579
• Device Lot Number: 4-4613-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown