BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO, OUS

    MDR report key: 3480914 · Received November 7, 2013

    Report

    Report Number
    2242352-2013-01553
    Event Type
    Injury
    Date Received
    November 7, 2013
    Date of Event
    October 23, 2013
    Report Date
    October 23, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    2242352-10/28/13-002R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE; THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. THE JAW BOOTS DISPLAYED EVIDENCE OF HEAT RELATED DAMAGE CONSISTENT WITH ACTIVATION OF THE DEVICE WITH THE JAWS IN DIRECT CONTACT. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A RESISTANCE POWER SUPPLY AND EXTENSION CABLE; THE DEVICE PASSED THE PRE-CAUTERY TEST AS IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATION AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. CYCLE LIFE TESTING WAS PERFORMED ON THE DEVICE; THE DEVICE PASSED THE 60 CYCLES OF TESTING. THE DEVICE HANDLE WAS OPENED TO VERIFY CONNECTIONS; UNDER MAGNIFICATION, SOLDERING FLUX WAS OBSERVED ON THE SWITCH BODY, LEVER, AND ACTUATOR OF THE MICRO SWITCH. NO NONCONFORMITIES WERE OBSERVED WITH THE SOLDER JOINTS. BASED UPON THE EVAL RESULTS, THE COMPLAINT COULD NOT BE CONFIRMED. THE FOLLOWING CORRECTIVE ACTION HAS BEEN TAKEN TO ADDRESS THE SOLDER FLUX ISSUE: MAQUET HAS REVISED THE WORK INSTRUCTION FOR THE SOLDERING PROCESS MPI2047401/HANDLE ASSEMBLY MPI2047410 TO ADD ENHANCED VISUAL INSPECTION TO THE SOLDERING POINTS AND THE SWITCH CONTAMINATION WITH FLUX. MAQUET CARDIOVASCULAR LLC HAS INITIATED RECALL 2242352-10/28/13-002R TO ADDRESS THIS FAILURE MODE. THE FDA NJ DISTRICT RECALL COORDINATOR HAS BEEN ADVISED. A NOTIFICATION LETTER HAS BEEN SENT TO THIS CUSTOMER. NOTE: FDA HAS NOT YET ASSIGNED A "Z" NUMBER TO THIS ACTION. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO DEVICE ACTIVATED WITHOUT ENGAGING THE TOGGLE SWITCH AFTER THE CABLE AND POWER SUPPLY WERE SET UP. THE PT'S LEG WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576754 VASOVIEW HEMOPRO, OUS ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000-W 25077051

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other