BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3031043 · Received March 28, 2013

    Report

    Report Number
    2242352-2013-00277
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMOPRO DEVICES AND CANNULAS WERE RETURNED TO THE FACTORY FOR EVALUATION. THEY SHOWED SIGNS OF CLINICAL USAGE AND SLIGHT EVIDENCE OF BLOOD. THE SCOPE WASHER TUBE, HALF OF THE C-RING, AND PAT OF THE SILICONE JAW BOOT ON THE HOT JAW WERE MISSING FROM THE FIRST DEVICE; THE OTHER HALF OF THE C-RING AND BLUNT TIP OF THE CANNULA WERE PARTIALLY MELTED. ON THE SECOND DEVICE, IT APPEARED THAT THE JAWS WERE ACTIVATED WHILE IN DIRECT CONTACT WITH EACH OTHER AS THERE WAS HEAT DAMAGE EVIDENT. A PRE-CAUTERY TEST WAS PERFORMED ON BOTH DEVICES WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE AS WELL AS THE RETURNED CABLE. BOTH PASSED AS THEY PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OF WHEN THE TOGGLE WAS RELEASED. THE HANDLES ON THE DEVICES WERE OPEN TO VERIFY CONNECTIONS AND NO NON CONFORMITIES WERE OBSERVED. WHILE WE WERE UNABLE TO DUPLICATE THE REPORTED FAILURES DURING TESTING, THE REPORTED EVENT IS LIKELY ATTRIBUTABLE TO AN IMPROPER CONNECTION BETWEEN THE TOOL AND THE EXTENSION CABLE. PER THE DEVICE'S IFU, THE EXTENSION CABLE MUST BE FULLY SEATED TO THE HARVESTING TOOL TO ENSURE PROPER FUNCTION. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THE EVALUATION RESULTS AND A COPY OF THE IFU WERE PROVIDED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING THE HEMOPRO DEVICE, THERE WAS HEAT RELATED DAMGE TO THE C-RING. A REPLACEMENT HEMOPRO DEVICE AND EXTENSION CABLE WERE USED; HOWEVER, THE SAME ISSUE OCCURRED. AN ADD'L REPLACEMENT DEVICE AND DC EXTENSION CABLE WERE USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. REFER TO MFR REPORT # 2242352-2013-00278.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127812 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25069284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA