BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUWAVE, VAMP PLUS

    MDR report key: 21715515 · Received March 27, 2025

    Report

    Report Number
    2015691-2025-02337
    Event Type
    Injury
    Date Received
    March 27, 2025
    Report Date
    March 27, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    UDI-DI
    07460691950108
    PMA / PMN Number
    K142749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED 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. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING STATEMENTS REGARDING MRI SAFETY: THIS DEVICE AND THE ASSOCIATED CABLE ARE NOT INTENDED FOR USE INSIDE OF THE BORE OF THE MR SYSTEM AND SHOULD NOT BE IN CONTACT WITH THE PATIENT. THIS DEVICE AND THE ASSOCIATED CABLE MAY BE IN THE MR SYSTEM ROOM BUT NOT IN OPERATION OR CONNECTED TO A PRESSURE MONITORING SYSTEM DURING AN MR EXAMINATION. 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 PART OF THE MONTHLY REVIEW. ADDITIONAL FDA PRODUCT CODE: KRA. ADDITIONAL PREMARKET SUBMISSION: K181684 AND K896819.

    Description of Event or Problem · 0

    AS REPORTED, A PATIENT RECEIVED A MAGNETIC RESONANCE IMAGING (MRI) THERMAL BURN WHILE CONNECTED TO THIS PRESSURE MONITORING SYSTEM. THE TRANSDUCER WAS LOCATED AT THE PATIENT'S HUMERUS AND CONNECTED TO AN IRADIMED ARTERIAL LINE MONITORING POD. THE PATIENT REQUIRED WOUND CONSULTS AND MEDICATED CREAM FOR THE THERMAL INJURY ON THE RIGHT HUMERUS. NO SURGICAL INTERVENTION WAS REQUIRED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PRODUCT NON-CONFORMANCE WITH THE PRESSURE MONITORING KIT AND THEY WILL PROVIDE EDUCATION TO THEIR HOSPITAL STAFF REGARDING MRI SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373763 TRUWAVE, VAMP PLUS TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PXVP2260 07460691950108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other