BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 EXTENSION CABLE

    MDR report key: 4152238 · Received October 3, 2014

    Report

    Report Number
    2242352-2014-01048
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE THUMB SWITCH DID NOT ACTIVATE THE VASOVIEW HEMOPRO 2. THEY TRIED TO SWITCH OUT THE CORD AND DURING THE PROCESS OF EXCHANGE, THE DEVICE WAS BROKEN. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617283 HEMOPRO2 EXTENSION CABLE ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4030

    Patients

    Seq Age Sex Outcome Treatment
    1