MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC PRISMAFLEX SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	107142
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It is reported that an external fluid leak was observed from an unspecified location of a prismaflex hf1400 set during priming.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H11: the device was received for evaluation.Visual inspection of the actual sample did not identify any abnormalities that could have contributed to the reported leakage event.An air leak test was performed (2 bar), and a leak was observed at the level of the access post-pump line.Further inspection showed that the access post-pump line was perforated near the filter screwed connector.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 damaged tubing was not determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SET
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av. lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 22872079
• Report Number: 8010182-2025-00495
• Device Sequence Number: 20277603
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: 07332414069315
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K042938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 107142
• Device Lot Number: 25B0071CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6).
• Patient Sex: Unknown