BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS ARTERIAL BLOOD MGMT PROT SYSTEM

    MDR report key: 4044433 · Received August 28, 2014

    Report

    Report Number
    2015691-2014-02010
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 4, 2014
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE VAMP ADULT SYSTEM WAS RECEIVED FOR PRODUCT EVALUATION. THE TUBING WAS FOUND DETACHED FROM THE BOND JOINT WITH THE RESERVOIR STOPCOCK. THE TUBING WAS BENT NEAR THE POINT OF DAMAGE. THERE WERE INDICATIONS THAT THE BONDING SOLVENT WAS VISIBLE AT APPROXIMATELY 50% OF THE TUBING BOND AREA. THE TUBING OD NEAR THE POINT OF DETACHMENT WAS WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE MET SPECIFICATIONS UPON DISTRIBUTION. THE COMPLAINT WAS CONFIRMED BY EVALUATION. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DISCONNECTION OF THE TUBING TO THE STOPCOCK BETWEEN THE PUMP AND THE ARTERIAL CATHETER. THERE WAS A DISAPPEARANCE OF THE ARTERIAL PRESSURE SIGNAL WHICH CAUSED AN ALARM THAT ALERTED THE CLINICIAN. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524766 VENOUS ARTERIAL BLOOD MGMT PROT SYSTEM VAMP ADULT SYSTEM DXO EDWARDS LIFESCIENCES DR 48VMP160 59750716

    Patients

    Seq Age Sex Outcome Treatment
    1