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

Catalog Number	107636US
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date: february 2026.Prismaflex st100 set has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.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 with a prismaflex st100 set, a "piece (luer lock connector) on crrt was broken where anticoagulation infuses" and resulted in the leakage of heparin "on the backside of the syringe".There was no report of serious injury associated with this event.No additional information is available.
Additional Manufacturer Narrative
H11: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MEYZIEU; 7, av. lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24730261
• Report Number: 8010182-2026-00262
• Device Sequence Number: 13309799
• Product Code: KDI
• UDI-Device Identifier: 00085412954073
• UDI-Public: 00085412954073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K212216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: 107636US
• Device Lot Number: ASKU
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/01/2026
• 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: HEPARIN
• Patient Age: 12 YR
• Patient Sex: Male