BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 3547211 · Received November 26, 2013

    Report

    Report Number
    2242352-2013-01628
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    November 6, 2013
    Report Date
    November 6, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND 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 PASSED THE PRE-CAUTERY TEST; IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. THE DEVICE ALSO PASSED THE ENGINEERING (B)(4) CYCLE LIFE TEST. THE HANDLE ON THE DEVICE WAS OPENED TO VERIFY CONNECTIONS. BASED UPON THE EVALUATION RESULTS, THE REPORTED 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 (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 THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE POWER WOULD NOT SHUT OFF AND THE JAWS OVERHEATED ON THE VASO VIEW HEMOPRO. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS AND THE VEIN WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616789 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25083384

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR