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

Catalog Number	107140
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
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 that during continuous renal replacement therapy using of a prismaflex hf 1000 set, ¿the stop cock and connection to the epo syringe was cracked" and leaked blood.The volume of blood loss was not known.There was no report of medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h6, h11.H11: the device was received for evaluation.Visual inspection of the actual sample showed a crack in the set anticoagulant line connector, 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 customer reported that the drug flolan (epoprostenol) was in use during therapy.Epoprostenol is not compatible with the polyethylene terephthalate glycol components of the prismaflex set.Per the set instructions for use, the drug should not be injected into the anticoagulation line as component damage can occur which may result in a leak.The reported condition was verified.The cause of the condition was determined to be related to unintended use error.A previous nonconformance was opened to address this issue.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: 22811201
• Report Number: 8010182-2025-00478
• Device Sequence Number: 7798240
• Product Code: KDI
• UDI-Device Identifier: 07332414069254
• UDI-Public: 07332414069254
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 107140
• Device Lot Number: 24G0034CB
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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: EPOPROSTENOL.
• Patient Age: 18 YR
• Patient Sex: Male