BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIDECO ELECTRA AUTOTRANSFUSION KIT

    MDR report key: 785279 · Received September 6, 2006

    Report

    Report Number
    1718850-2006-00046
    Event Type
    Malfunction
    Date Received
    September 6, 2006
    Date of Event
    May 25, 2006
    Report Date
    June 30, 2006
    Manufacturer
    SORINE 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
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED WAS RETURNED AND VISUALLY AND DIMENSIONALLY INSPECTED. THE INSPECTION FOUND A DEFECTIVE COUPLING ANGLE BETWEEN THE CENTRIFUGE MOUNTING RING AND THE BOTTOM 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

    THE BOWL MADE AN ABNORMAL SOUND. THE MACHINE WOULD NOT RECOGNIZE THE BOWL SIZE, DURING THE SET UP, SO THE OPERATOR REPLACED THE BOWL BEFORE PROCEEDING WITH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO ELECTRA AUTOTRANSFUSION KIT APPARATUS, AUTOTRANSFUSION CAC SORINE GROUP ITALIA S.R.L. NA 0602030111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA