BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIDECO ELECTA AUTOTRANSFUSION KIT

    MDR report key: 782723 · Received September 6, 2006

    Report

    Report Number
    1718850-2006-00035
    Event Type
    Malfunction
    Date Received
    September 6, 2006
    Date of Event
    July 27, 2006
    Report Date
    August 11, 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 Location
    SN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COBE CARDIOVASCULAR INC. IS THE DISTRIBUTOR OF A SIMILAR PRODUCT SOLD IN THE US. COD.745E/175 DOES CONTAIN THE COMPONENT THAT IS INVOLVED IN THE US FIELD CORRECTION; THEREFORE, A MEDWATCH REPORT WAS DETERMINED TO BE APPROPRIATE. 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 BUTTON OF THE BOWL. ADDITIONAL EVALUATION WAS PERFORMED ON THE WASH SETS IN THE BRACKET THAT INCLUDED THIS LOT. THAT EVALUATION INCLUDED PERFORMANCE TESTING AND 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

    LOUD NOISE WERE HEARD FROM THE ELECTA BOWL DURING HCT CALIBRATION. THE PROCEDURE WAS STOPPED AND BLACK SPECKS WERE SEEN IN THE BOWL OF THE WASH KIT.

    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 0602030111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA