BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTA WASH SET 225 ML BOWL

    MDR report key: 779036 · Received August 30, 2006

    Report

    Report Number
    1718850-2006-00030
    Event Type
    Malfunction
    Date Received
    August 30, 2006
    Date of Event
    July 19, 2006
    Report Date
    July 21, 2006
    Manufacturer
    SORIN GRP ITALIA S.R.I., A SORIN GRP CO., DISTRIBUTED BY COBE CARDIOVASCULAR INC
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WASH SET INVOLVED IN THIS ISSUE WAS RETURNED AND VISUALLY INSPECTED. THE INSPECTION CONFIRMED THE PRESENCE OF DEBRIS. HOWEVER, THE CONCLUSION IS BASED ON EVALUATION OF WASH SETS IN A BRACKET THAT INCLUDED THIS LOT. THAT EVALUATION INCLUDED PERFORMANCE TESTING AND REVEALED THAT IF THE BOWL CANNOT BE INSERTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THERE IS A RISK THAT THE BOWL'S ROTATING SEAL AREA COULD DETERIORATE DURING CENTRIFUGING, RELEASING PARTICULATE 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 THE MANUFACTURER. BASED ON THE EVENT DESCRIBED IN G4 ABOVE. SORIN GROUP ITALIA COMPLETED A RISK ASSESSMENT THAT LEAD TO A FIELD NOTIFICATION. THE FIELD NOTIFICATION IN THE U.S. WAS CONDUCTED BY COBE CARDIOVASCULAR, INC., THE DISTRIBUTOR OF THIS DEVICE. THE Z-NUMBER WILL BE PROVIDED WHEN IT IS AVAILABLE FROM THE LOCAL FDA OFFICE.

    Description of Event or Problem · 1

    DURING SET-UP, THE USER FOUND BLACK AND WHITE SPOTS INSIDE THE BOWL OF THE WASH SET. THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTA WASH SET 225 ML BOWL APPARATUS, AUTOTRANSFUSION CAC SORIN GRP ITALIA S.R.I., A SORIN GRP CO., DISTRIBUTED BY COBE CARDIOVASCULAR INC NA 0603030049

    Patients

    Seq Age Sex Outcome Treatment
    1