BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 1930673 · Received December 15, 2010

    Report

    Report Number
    1124841-2010-00143
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    June 17, 2010
    Report Date
    August 25, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    KFM
    PMA / PMN Number
    K020998
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE AND WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS SURGERY THE CENTRIFUGAL PUMP DISCONNECTED. THE CENTRIFUGAL PUMP WAS RECONNECTED; THERE WAS 600ML OF BLOOD LOSS, AND THE PT NEEDED TO BE TRANSFUSED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS CENTRIFUGAL PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention