BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3943794 · Received April 30, 2014

    Report

    Report Number
    2242352-2014-00478
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THERE WERE MULTIPLE CRACKS ON THE SILICONE BOOT ON THE COLD JAW. THE BOOTS DISPLAYED EVIDENCE OF HEAT RELATED DAMAGE CONSISTENT WITH ACTIVATION OF THE DEVICE WHILE THE JAWS ARE IN DIRECT CONTACT. WHILE WE WERE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE, THIS PROBLEM IS CONSISTENT WITH AN IMPROPER INSERTION OF THE TOOL INTO THE CANNULA. COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL CORRECTIVE ACTION ((B)(4)) ISSUED FOR THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SILICONE ON THE JAW OF THE VASO VIEW HEMOPRO CAME OFF. NOTHING FELL INTO THE PATIENT. 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
    258288 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25093295

    Patients

    Seq Age Sex Outcome Treatment
    1