BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3558299 · Received October 31, 2013

    Report

    Report Number
    2242352-2013-01489
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 7, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMOPRO DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. 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 JAWS 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 AS IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. CYCLE LIFE TESTING WAS PERFORMED ON THE DEVICE; THE DEVICE PASSED THE (B)(4) 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 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 THIS CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO DEVICE REMAINED ACTIVATED. A PRE-CAUTERY TEST WAS PERFORMED. THE CASE WAS STARTED AND THE UNIT STAYED ACTIVATED AFTER SEVERAL BRANCH DIVISIONS. FIRST, THE POWER CABLES WERE CHANGED AND THE SAME HEMOPRO UNIT WAS RETESTED; HOWEVER, THE DEVICE CONTINUED TO REMAIN ACTIVATED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561373 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25080351

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR