BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 EXTENSION CABLE

    MDR report key: 2160121 · Received May 13, 2011

    Report

    Report Number
    2242352-2011-00444
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE CABLE CONNECTOR JACKET WAS DETACHED WITH A CLEAN BREAK. BASED UPON THE VISUAL OBSERVATION, THE REPORTED COMPLAINT, "CABLE BROKE" WAS CONFIRMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN PREPARATION FOR ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO2 EXTENSION CABLE BROKE. THE BLACK PLASTIC PART OF CONNECTOR BROKE OFF. THIS WAS NOTICED WHEN THEY WERE TAKING OUT THE CABLE FROM THE STERILIZATION BAG. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS RETURNING BUT THAT PIECE THAT BROKE OFF IS NOT RETURNING.

    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