BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIDECO ELECTA AUTOTRANSFUSION KIT

    MDR report key: 777689 · Received September 6, 2006

    Report

    Report Number
    1718850-2006-00036
    Event Type
    Malfunction
    Date Received
    September 6, 2006
    Date of Event
    August 9, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COD.745E/225 DOES CONTAIN THE COMPONENT THAT IS INVOLVED IN THE US FILED CORRECTION; THEREFORE, A MEDWATCH REPORT WAS DETERMINED TO BE APPROPRIATE. RETURN OF THE DEVICE WAS REQUESTED, BUT HAS NOT YET ARRIVED. THE PRODUCT INVOLVED HAS NOT BEEN RETURNED FOR EVAL. HOWEVER, THE CONCLUSION IS BASED ON EVAL OF WASH SETS IN A BRACKET THAT INCLUDED THIS LOT. THAT EVAL 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 MFG PROCESS ERROR THAT RESULTED IN A SLIGHT DEFORMATION IN THE MOUNTING RING OF THE BOWL BOTTOM. THE PROCESS ERROR HAS SUBSEQUENTLY BEEN CORRECTED BY SORIN GROUP. SORIN GROUP ITALIA 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 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 THE SET-UP THE BOWL TURNED IN AN ECCENTRIC WAY. TRY TO CONTINUE WITH THE PRIME PHASE, BUT THE NOISE WAS TOO LOUD SO THE BOWL WAS REPLACED.

    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 0603030046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA