BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP PLUS

    MDR report key: 21953223 · Received May 2, 2025

    Report

    Report Number
    2015691-2025-03500
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    March 20, 2025
    Report Date
    June 16, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    UDI-DI
    07460691950436
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE TO SECURE THE RETURN OF THE DEVICE HOWEVER THE CUSTOMER HAS NOT RESPONDED NOR SENT THE DEVICE BACK FOR EVALUATION. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODE: KRA. ADDITIONAL FDA PREMARKET SUBMISSION: K181684, K896819. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEW IS UNABLE TO BE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHILE POWER FLUSHING, THE PIGTAIL OF A TRUWAVE BROKE. PER THE CUSTOMER, AN ACCURATE BLOOD PRESSURE WAS UNABLE TO BE OBTAINED AND THE ALINE WAS AT RISK FOR CLOTTING. THE DEVICE WAS EXCHANGED FOR A NEW ONE. THERE WERE NO PATIENT INJURIES. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187739 TRUWAVE, VAMP PLUS TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PXVP2284AT3 07460691950436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown