MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC POLYFLUX; DIALYZER, CAPILLARY, HOLLOW FIBER

Catalog Number	102057
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplement report will be submitted.
Event or Problem Description
It was reported that an external fluid leak was observed from a polyflux 14 l during hemodialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H11: the device was received for evaluation.Visual inspection of the actual sample showed the product filled with blood and decontamination was required prior to analysis.A leak test was performed on the dialysate side of the device and a leak was observed from a crack in the welding seam.During production, a 100% control is performed for the tightness of the welding seam.In the leak test for this lot, the measured values were within specification, and no increased scrap rate was detected.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 welding seam crack was not determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: POLYFLUX
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - HECHINGEN BADEN DIALYZER; holger-crafoord-strasse 26; hechingen, baden-wurttemberg 72379 ; GM 72379
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24639915
• Report Number: 9611369-2026-00035
• Device Sequence Number: 18659526
• Product Code: FJI
• UDI-Device Identifier: 07332414036423
• UDI-Public: 07332414036423
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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 Catalogue Number: 102057
• Device Lot Number: 5-5001-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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