BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET VASOVIEW HEMOPRO

    MDR report key: 1531995 · Received November 13, 2009

    Report

    Report Number
    MW5013527
    Event Type
    Other
    Date Received
    November 13, 2009
    Date of Event
    October 11, 2009
    Report Date
    November 13, 2009
    Manufacturer
    MQUET CARDIOVASCULAR
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE VASOVIEW HEMOPRO INSTRUMENT ACTIVATED ON ITS OWN DURING SURGERY, CAUSING THE DISTAL TIP OF THE DISPOSABLE HEMOPRO INSTRUMENT TO GLOW RED HOT. A SECOND INSTRUMENT CABLE WAS INSTALLED TO REPLACE THE INITIAL CABLE AND THE SAME CONSTANT ACTIVATION OCCURRED. SUBSEQUENT TESTING BY THE HOSPITAL'S BIOMEDICAL ENGINEERING DEPARTMENT SHOWED NO ANOMALIES AND THE VASOVIEW HEMOPRO INSTRUMENT FUNCTIONED PROPERLY WITH BOTH SUSPECT CABLES AND TWO SEPARATE CONTROL BOXES. IT WAS NOTED THAT WHEN THE CABLE IS NOT FULLY INSERTED INTO THE HEMOPRO INSTRUMENT, ACCIDENTAL ACTIVATION CAN OCCUR. THIS IS NOT AN OPTIMAL DESIGN IN OUR OPINION SINCE AN OPEN IN THE INTERFACE CABLE CAN CAUSE THE INSTRUMENT TO INADVERTENTLY ACTIVATE AND POSE A SURGICAL FIRE HAZARD. IT WAS NOTED THAT ONE OF THE THREE PINS ON THE INSTRUMENT END OF ONE CABLES TESTED WAS SLIGHTLY RECESSED AS COMPARED TO THE OTHER TWO PINS. IT IS POSSIBLE THAT THIS SLIGHTLY RECESSED PIN CAN CONTRIBUTE TO INADVERTENT INSTRUMENT ACTIVATION BY SIMULATING AN OPEN CIRCUIT ON ONE PIN. THE VASOVIEW HEMOPRO INSTRUMENT AND BOTH CABLES WERE RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET VASOVIEW HEMOPRO VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MQUET CARDIOVASCULAR VH-3000 9072971

    Patients

    Seq Age Sex Outcome Treatment
    1