BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIDECO ELECTA AUTOTRANSFUSION KIT

    MDR report key: 782695 · Received September 6, 2006

    Report

    Report Number
    1718850-2006-00049
    Event Type
    Malfunction
    Date Received
    September 6, 2006
    Date of Event
    May 26, 2006
    Report Date
    June 30, 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
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, THIS INCIDENT WAS CONSIDERED A NON REPORTABLE EVENT. AFTER RECEIVING AND ANALYZING SIMILAR COMPLAINTS, AT THE END OF JULY 2006, SORIN GROUP RECOGNIZED THERE WERE POTENTIAL RISKS FOR RELEASING PARTICULATES INTO THE PROCESSED BLOOD. IN ADDITION THE DELAY IN REPORTING WAS DUE MANUFACTURER'S MISUNDERSTANDING ABOUT THE NEED TO NOTIFY FDA OF EVENTS INVOLVING PRODUCT NOT DISTRIBUTED IN THE US. COBE CARDIOVASCULAR INC. IS THE DISTRIBUTOR OF A SIMILAR PRODUCT SOLD IN THE US. DATE THAT THE MANUFACTURER, SORIN GROUP, BECAME AWARE OF ANOTHER INCIDENT WHERE THE CONDITION PRESENT IN THIS LOT OF PRODUCT LED TO DEGRADATION OF THE SEAL AREA MATERIAL AND RELEASE OF PARTICLES INTO THE PROCESSED BLOOD. HE PRODUCT INVOLVED HAS NOT BEEN RETURNED FOR EVALUATION. THE CONCLUSION IS BASED UPON AN EVALUATION 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 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 NOISE DURING THE SET UP AND WOBBLED WHEN IT WAS SPUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO ELECTA AUTOTRANSFUSION KIT APPARATUS, AUTOTRANSUFUSION CAC SORIN GROUP ITALIA S.R.L NA 0602200074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA