BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIDECO ELECTA AUTOTRANSFUSION KIT

    MDR report key: 782738 · Received September 6, 2006

    Report

    Report Number
    1718850-2006-00038
    Event Type
    Malfunction
    Date Received
    September 6, 2006
    Report Date
    August 10, 2006
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COBE CARDIOVASCULAR INC. IS THE DISTRIBUTOR OF A SIMILAR PRODUCT SOLD IN THE US. THE PRODUCT INVOLVED WAS RETURNED AND VISUALLY AND DIMENSIONALLY INSPECTED. THE INSPECTION CONFIRMED THE PRESENCE OF DEBRIS AND FOUND A DEFECTIVE COUPLING ANGLE BETWEEN THE CENTRIFUGE MOUNTING RING AND THE BUTTOM OF THE BOWL. ADDITIONAL EVALUATION WAS PERFORMED ON THE WASH SETS IN THE BRACKET THAT INCLUDED THIS LOT. THAT EVALUATION INCLUDED PERFORMANCE TESTING AND REVEALED THAT IF THE BOWL CANNOT BE INSERTED INTO THE CENTRIFUGE IN ACCORDANCE WITH THE IFU, THERE IS A RISK THAT THE BOWL'S ROTATING SEAL AREA COULD DETERIORATE DURING OPERATION, RELEASING PARTICULATES INTO THE PROCESSED BLOOD. THE LOADING OF WASH SETS FROM THIS BRACKET OF PRODUCT CAN BE MORE DIFFICULT DUE TO A MANUFACTURING PROCESS ERROR THAT RESULTED IN A SLIGHT DEFORMATION IN THE MOUNTING RING ON THE BOWL BOTTOM. THE PROCESS ERROR HAS SUBSEQUENTLY BEEN CORRECTED BY SORIN GROUP. SORIN GROUP COMPLETED A RISK ASSESSMENT THAT LEAD TO A FIELD NOTIFICATION THAT INCLUDED THE PRODUCT SOLD IN THE US. THE FIELD NOTIFICATION IN THE US WAS CONDUCTED BY COBE CARDIOVASCULAR, INC., THE DISTRIBUTOR OF THE US DEVICES. THE LOCAL FDA OFFICE WAS NOTIFIED OF THE FIELD ACTION AND THE REPORTING NUMBER WILL BE PROVIDED WHEN IT IS AVAILABLE.

    Description of Event or Problem · 1

    DURING PRIMING, THE ELECTA MACHINE MADE LOUD NOISE THEN ALARMED AND STOPPED WORKING. ON INSPECTION OF BOWL, GREY PARTICLES WERE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO ELECTA AUTOTRANSFUSION KIT APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP ITALIA S.R.L. NA 0603100014

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO