BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2770280 · Received October 1, 2012

    Report

    Report Number
    2242352-2012-01013
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THIS REVIEW CONFIRMED THAT ALL PRODUCT AND PACKAGING COMPONENTS STAGED FOR THIS LOT WERE CONSUMED; THEREFORE, WE ARE UNABLE TO CONFIRM THE CUSTOMER'S REPORT THAT THERE WERE ITEMS MISSING. A REPLACEMENT WAS PROVIDED AS A CUSTOMER ACCOMMODATION. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, UPON OPENING THE STERILE PACKAGE, THE FOAM, HEMOPRO 2 DEVICE AND ACCESSORY KIT WERE NOT IN THE BOX. THE PLASTIC CLAMSHELL AND ACCESSORY KIT TRAY WERE THE ONLY ITEMS IN THE PACKAGING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE HOSP WILL REPORTEDLY NOT BE RETURNING THE PACKAGING AS IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25059924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA