BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 EXTENSION CABLE

    MDR report key: 3871303 · Received April 15, 2014

    Report

    Report Number
    2242352-2014-00436
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. THE DEVICES SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE COVER OF THE END OF THE CABLE WAS DISLOCATED AND RETURNED. THE DETACHMENT OF THE CONNECTOR COLLAR IS POTENTIALLY ATTRIBUTED TO USER TECHNIQUE. AS STATED IN THE HEMOPRO 2 IFU, THE USER IS INSTRUCTED TO PULL BACK ONLY ON THE EXTENSION CABLE CONNECTOR COLLAR WHEN DISCONNECTING THE EXTENSION CABLE. BASED UPON THE EVAL RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE CONNECTOR ON THE HEMOPRO2 EXTENSION CABLE BROKE OFF THE CORD. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230571 HEMOPRO2 EXTENSION CABLE ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA