BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1732536 · Received June 15, 2010

    Report

    Report Number
    1212122-2010-00024
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Report Date
    May 21, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO RECEIVED A PHOTOGRAPHIC IMAGE OF THE ACTUAL DEVICE FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE TUBING HAD A KINK IN IT WHERE IT ATTACHES TO THE CENTRIFUGAL PUMP. THE LOCATION OF THE CENTRIFUGAL PUMP IN THE PACK HAS BEEN CHANGED SINCE THIS PACK WAS DESIGNED. A PRODUCTION ALERT HAS BEEN ADDED TO THE SPECIFICATION TO INSPECT PACKS DURING NEXT BUILD. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY TO TERUMO CARDIOVASCULAR THAT DURING SET-UP THERE WAS A KINK IN THE TUBING THAT CONNECTS TO THE CENTRIFUGAL PUMP. THE PRODUCT WAS NOT CHANGED OUT, NO BLOOD LOSS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA MA25

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK