BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2160209 · Received June 2, 2011

    Report

    Report Number
    2242352-2011-00554
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 9, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIOVASCULAR FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 DEVICE STARTED WORKING INTERMITTENTLY. THE PROCEDURE WAS 99% COMPLETE, WHEN THE DEVICE WOULD SHUT DOWN AFTER ABOUT 1-2 SECONDS. THE USER WAITED 30 SECONDS, ACTIVATED AGAIN, AND IT WAS STILL INTERMITTENT. THE USER DOES NOT BELIEVE IT WAS THE SAFETY SHUT DOWN OCCURRING, AND HAD NOT EXPERIENCED THE SAFETY SHUT DOWN PRIOR TO THIS OCCURRING. THE CORD WAS CHANGED, BUT THE PROBLEM PERSISTED. A NEW KIT WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25031968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA