BEUDAMED
    FDA Adverse Event Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 2001872 · Received February 18, 2011

    Report

    Report Number
    1124841-2011-00041
    Date Received
    February 18, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K020998
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCES EVAL CODES. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SET-UP, THE CENTRIFUGAL PUMP MADE A SQUEALING NOISE DURING RECIRCULATION. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING SET-UP. 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. 164275X ML27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK