BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2398536 · Received November 7, 2011

    Report

    Report Number
    2242352-2011-01671
    Event Type
    Malfunction
    Date Received
    November 7, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 1, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED, SINCE THE LOT NUMBER WAS NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THREE OF THE HEMOPRO 2 REMAINED ACTIVATED. THE REPORTER STATED "AFTER THEY RELEASED THE ACTIVATION TOGGLE, THERE IS CONTINUOUS ACTIVATION FOR A MINIMUM OF 3 SECONDS. THEY FEEL THAT EVEN THOUGH THE GENERATOR AND DEVICE ARE NO LONGER "ACTIVATED" THAT THERE IS STILL HEAT BEING EMITTED FROM THE TIP." THE SAME UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. IT IS UNKNOWN IF THE PRODUCT IS RETURNING. REFER TO MW #S 2242352-2011-01670 AND 2242352-2011-01672. MAQUET CARDIOVASCULAR ANTICIPATES THE RETURN OF THE PRODUCT IN QUESTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI