BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMC LAS VEGAS NV1

    MDR report key: 1051189 · Received May 22, 2008

    Report

    Report Number
    1718850-2008-00012
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 23, 2008
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTN
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOM PERFUSION PACK, CATALOG NUMBER 067757001, IS A PRE-AMENDMENT DEVICE. A REVIEW OF THE MANUFACTURING RECORDS INDICATE THAT THE VVR 4000I WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. VISUAL INSPECTION OF THE RESERVOIR REVEALED THAT APPROXIMATELY 2/3 OF THE DEFOAMER WAS WETTED OUT WITH BLOOD. THERE WERE SEVERAL BLOOD CLOTS SEEN IN THE CARDIOTOMY FILTER. HOWEVER, THE FILTER DID NOT APPEAR TO BE BLOCKED OR CLOTTED OFF. FLUID WAS INTRODUCED INTO THE CARDIOTOMY PORTS AND OBSERVED FOR BREAKTHROUGH OR HOLD UP TO ASSESS PERFORMANCE DEGRADATION DUE TO AN OCCLUSION OR CLOTS. THE CARDIOTOMY FILTER BREAKTHROUGH VOLUME WAS WITHIN NORMAL RANGE. THE VENOUS RESERVOIR WAS SUBJECTED TO A 6 LPM FLUID FLOW TEST. THERE WAS NO FLOW RESISTANCE, HOLD UP OR DECREASE IN FLOW RATE. LABORATORY TESTING CONFIRMED THAT THE CARDIOTOMY FILTER AND VENOUS RESERVOIR DEFOAMER PERFORMED WITHIN PRODUCT SPECIFICATIONS. THE REPORTED FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    AFTER GOING ON BYPASS, THE PERFUSIONIST NOTICED BUBBLES COMING OUT OF THE CARDIOTOMY RESERVOIR PORTION OF A VENOUS RESERVOIR. THE PERFUSIONIST REQUESTED A STAND ALONE REPLACEMENT CARDIOTOMY RESERVOIR. BEFORE THE RESERVOIR COULD BE REPLACED, IT WAS REPORTED THAT THE ARTERIAL FLOW HAD DROPPED TO .5 LPM. THE PERFUSIONIST WAS UNABLE TO MAINTAIN ADEQUATE FLOW AS A RESULT OF AN INSUFFICIENT VENOUS RETURN. THE DEVICE WAS REPLACED AND BYPASS WAS RESUMED. NO ADVERSE PATIENT EFFECT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMC LAS VEGAS NV1 CUSTOM PERFUSION PACK DTN SORIN GROUP USA, INC. NA 0721800116

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR