BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP

    MDR report key: 21660113 · Received March 20, 2025

    Report

    Report Number
    2015691-2025-02122
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    January 27, 2025
    Report Date
    April 30, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    UDI-DI
    07460691955103
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE DETACHMENT ISSUE HAS BEEN INVESTIGATED BY THE APPLICABLE CROSS FUNCTIONAL TEAM AND AS PART OF THE COMPLAINT INVESTIGATION PROCESS, NO SPECIFIC ROOT CAUSE WAS IDENTIFIED. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS UNDERGO VISUAL INSPECTION, MANUFACTURING CONTINUOUS MONITORING SAMPLING, AND QUALITY ASSURANCE SAMPLING INSPECTION.

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED PRESSURE TUBING WITH VAMP. THE REPORTED EVENT OF "TUBING DISCONNECTED ABOVE THE VAMP" WAS CONFIRMED. AS RECEIVED PRESSURE TUBING WAS FOUND COMPLETELY DETACHED FROM VAMP RESERVOIR BOND JOINT. INDICATIONS OF WHAT APPEARED TO BE BONDING MATERIAL WERE EVIDENT ON TUBING BOND SURFACE AREA. TUBING OUTER DIAMETER, 0.1415" NEAR THE POINT OF DETACHMENT, WAS WITHIN SPECIFICATION. NO OTHER VISIBLE DAMAGE OR INCONSISTENCY WAS FOUND FROM RETURNED KIT. THE ENGINEERING EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD CANNOT BE REVIEWED. 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 FDA PRODUCT CODE IS KRA. ADDITIONAL FDA PREMARKET SUBMISSION ARE K173586 AND K896819.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VAMP PRESSURE TUBING BROKE AT THE VAMP ON THE IV SIDE. EVENT OCCURRED DURING ROUTINE BLOOD DRAW OFF THE ARTERIAL LINE, TWO DAYS AFTER SET UP. THE POINT OF DISCONNECTION WAS NOT A LUER SLIP NOR LUER LOCK AND THE LINE WAS UNABLE TO BE RE-ATTACHED. THIS PRESSURE TUBING WAS EXCHANGED FOR A NEW SET UP. THERE WERE NO INJURIES TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334704 TRUWAVE, VAMP TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PXVMP184 07460691955103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown