BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 3599421 · Received November 21, 2013

    Report

    Report Number
    2242352-2013-01605
    Event Type
    Malfunction
    Date Received
    November 21, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 1, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND NO EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE BOOTS DISPLAYED EVIDENCE OF HEAT RELATED DAMAGE CONSISTENT WITH ACTIVATION OF THE DEVICE WHILE THE JAWS ARE 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, IT SELF-ACTIVATED. THE HANDLE ON THE DEVICE WAS OPEN TO VERIFIED CONNECTIONS; UNDER MAGNIFICATION, SOLDER FLUX WAS OBSERVED ON THE SWITCH BODY, LEVEL AND ACTUATOR OF THE MICRO-SWITCH. THE FLUX CAUSED THE MICRO-SWITCH ACTUATOR TO BE STUCK IN THE "ON" POSITION. BASED UPON THE EVAL RESULTS, THE REPORTED 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 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 AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASO VIEW HEMOPRO DEVICE REMAINED ACTIVATED. 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
    607910 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25081204

    Patients

    Seq Age Sex Outcome Treatment
    1 NI