BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 EXTENSION CABLE

    MDR report key: 2201428 · Received August 3, 2011

    Report

    Report Number
    2242352-2011-01132
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Report Date
    July 28, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AFTER AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO 2 CABLE WIRE ENDS WERE EXPOSED; CONNECTOR PIECE THAT COVERS THE WIRE CAME OFF. NO REPLACEMENT WAS NEEDED AS THE PROCEDURE HAD ALREADY BEEN COMPLETED. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. EVENT DATE IS UNK. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA