BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 EXTENSION CABLE

    MDR report key: 2152401 · Received June 24, 2011

    Report

    Report Number
    2242352-2011-00679
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE FOUR CONNECTION END OF THE CABLE WAS EXPOSED AND THE HOUSING HAD COME LOOSE. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "CONNECTOR BROKEN" WAS CONFIRMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BLACK CONNECTOR OF THE VASOVIEW HEMOPRO 2 ADAPTOR WAS FOUND TO BE BROKEN. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOPRO2 EXTENSION CABLE CABLE GEI MAQUET CARDIOVASCULAR, LLC VH-4030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA