BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP

    MDR report key: 21866217 · Received April 18, 2025

    Report

    Report Number
    2015691-2025-03026
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 31, 2025
    Report Date
    July 14, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRA
    UDI-DI
    07460691950405
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: DXO. ADDITIONAL PREMARKET SUBMISSION: K173586, K896819. A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED PRESSURE MONITORING KIT. THE REPORTED EVENT OF "COULD NOT BE PRIMED" WAS NOT ABLE TO BE CONFIRMED. RETURNED KIT WAS ABLE TO BE PRIMED WITHOUT INDICATION OF FLOW RESTRICTION AND FLUSHED WITHOUT ANY PROBLEM. FLUSH DEVICE FUNCTIONED PROPERLY. HOWEVER, AS RECEIVED, PRESSURE TUBING WAS FOUND COMPLETELY DETACHED FROM VAMP RESERVOIR BOND JOINT. THERE WAS NO CLEAR INDICATION OF BONDING MATERIAL ON TUBING BOND SURFACE AREA. TUBING OUTER DIAMETER WAS WITHIN SPECIFICATION. NO OTHER VISIBLE DAMAGE OR INCONSISTENCY WAS FOUND TO THE RETURNED KIT. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION AND PREVIOUS EVALUATIONS, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/ DESIGN DEFECT. AS PART OF THE MANUFACTURING PROCESS ,100% OF THE UNITS GO THROUGH A VISUAL AND FUNCTIONAL INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING DEVICE PREP, A PRESSURE MONITORING KIT COULD NOT BE PRIMED PROPERLY. ISSUE WAS RESOLVED BY EXCHANGING THE DEVICE. ALTHOUGH THE ISSUE CAUSED A DELAY IN TREATMENT, THERE WERE NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19389 TRUWAVE, VAMP CATHETER, CONTINUOUS FLUSH KRA EDWARDS LIFESCIENCES DR PXVMP172AT3 66030637 07460691950405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown