BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3581576 · Received November 19, 2013

    Report

    Report Number
    2242352-2013-01583
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    October 24, 2013
    Report Date
    October 29, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    2242352-10/28/13-002R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMOPRO DEVICE WAS RETURNED TO THE FACTOR FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND THERE WAS 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 REFERENCE POWER SUPPLY AND EXTENSION CABLE; THE DEVICE DID NOT PASS THE PRE-CAUTERY TEST AS IT STAYED IN THE 'ON' POSITION. 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 WAS 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 WAS INITIATED RECALL 2242352-10/28/2013-002R 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 ASSIGNED A "Z" NUMBER TO THIS ACTION. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASO VIEW HEMOPRO REMAINED ACTIVATED AND STARTED TO SMOKE. THE DEVICE WAS REMOVED FROM THE PT'S LEG. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598545 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25079982

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR