BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3577314 · Received November 14, 2013

    Report

    Report Number
    2242352-2013-01542
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    October 10, 2013
    Report Date
    October 21, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    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

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNKNOWN. THE FOLLOWING CORRECTIVE ACTION HAS BEEN TAKEN TO ADDRESS THE SOLDER FLUX ISSUE: MAQUET HAS REVISED THE WORK INSTRUCTION FOR THE SOLDERING PROCESS (B)(4)/ HANDLE ASSEMBLY (B)(4) TO ADD ENHANCED VISUAL INSPECTION TO THE SOLDERING POINTS AND THE SWITCH CONTAMINATION WITH FLUX. MAQUET CARDIOVASCULAR LLC HAS INITIATED RECALL (B)(4) TO ADDRESS THIS FAILURE MODE. THE FDA (B)(4) DISTRICT RECALL COORDINATOR HAS BEEN ADVISED. A NOTIFICATION LETTER HAS BEEN SENT TO THIS CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE HEMOPRO FAILED TO DEACTIVATE AND SMOKE WAS OBSERVED IN THE TUNNEL. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO THE FACTORY FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591343 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTER DXC MAQUET CARDIOVASCULAR LLC VH-3000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI