MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC PRISMAFLEX SETS (M & ST); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	107640US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was receiving continuous renal replacement therapy (crrt) treatment using prismaflex st 150 set.It was reported that the control unit generated an alarm and it found that a ¿portion of the circuit from the access pressure sensor pod to the blood pump would be filled with air¿.It was reported that 15-16 "circuits" were used between this patient and another patient.The patient¿s treatment was terminated without the extracorporeal (ec) blood being returned to the patient.The patient required a blood transfusion due to drop in hemoglobin.Three days after the event, a new set was placed and no further issues were reported.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h6, h11.H11: the actual device was not available; however, three (3) photographs of the sample were provided for evaluation.Visual inspection of the photos confirmed the presence of air bubbles in the access circuit.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 condition was not determined as no further or actual sample testing could be performed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SETS (M & ST)
• 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): VANTIVE 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: 22293171
• Report Number: 8010182-2025-00330
• Device Sequence Number: 21063280
• Product Code: KDI
• UDI-Device Identifier: 00085412917696
• UDI-Public: (01)00085412917696(10)24K0076(17)261031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 107640US
• Device Lot Number: 24K0076
• 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: 05/24/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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: PRISMAFLEX MACHINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown