BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2080946 · Received April 13, 2011

    Report

    Report Number
    2242352-2011-00337
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE LOT NUMBER COULD NOT BE OBTAINED, SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 JAWS CONTINUED TO ACTIVATE. THE HARVESTER QUICKLY REMOVED THE DEVICE AND UNPLUGGED THE UNIT. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS RETURNING. THE HOSPITAL WILL RETAIN THE PRODUCT FOR INVESTIGATION BEFORE SENDING IT TO US, SO IT WILL TAKE SOME TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA