BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1832297 · Received September 3, 2010

    Report

    Report Number
    2242352-2010-02705
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 8, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(6)2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THE COLD JAW OF THE HEMOPRO WAS SLIGHTLY BURNT AND THE HEATER WAS BOWED OUT SLIGHTLY. THE JAWS SHOWED SIGNS OF CLINICAL USAGE. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. RESISTANCE MEASUREMENTS WERE OUT OF SPECIFICATION. A PRE-CAUTERY TEST WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE DID NOT PERFORM ACCORDING TO SPECIFICATIONS DURING SEVERAL DEVICE ACTIVATIONS, THE DEVICE WOULD NOT PRODUCE STEAM. BASED UPON THE FUNCTIONAL TEST, THE REPORTED COMPLAINT FOR "NO POWER" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. (B)(4)

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HARVESTER WAS GOING TO DO PRE-TESTING AND AFTER HOOKING UP THE CABLES TO THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, NOTHING HAPPENED. SHE SWAPPED OUT THE CABLE AND THE DEVICE SELF-ACTIVATED, IT BECAME VERY HOT, SMOKING AND WITH FLAMES. SHE GOT ANOTHER KIT AND CONNECTED IT USING THE ORIGINAL CABLE AND EVERYTHING WORKED FINE AND SHE WAS ABLE TO DO THE PRE-TESTING. THE CASE WAS THEN COMPLETED WITH THE SECOND KIT AND THE ORIGINAL CABLE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25016810

    Patients

    Seq Age Sex Outcome Treatment
    1 NA