BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 1982428 · Received January 26, 2011

    Report

    Report Number
    1124841-2011-00011
    Event Type
    Other
    Date Received
    January 26, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K020998
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION. VISUAL INSPECTION NOTED NO ANOMALIES. THE COMPLAINT SAMPLE AS WELL AS 6 ADDITIONAL SAMPLES WERE MEASURED ON THE OPTICAL COMPARATOR AND INLET BARB DIAMETERS FELL WITHIN TCVS SPECIFICATIONS. PULL TESTING WAS PERFORMED TO DETERMINE TIE-BANDED X-COATED TUBING DISCONNECT FORCE, ALL SAMPLES MET SPECIFICATIONS. THE TUBING THE CUSTOMER USED AND CONNECTION MADE MAY HAVE CONTRIBUTED TO THE DISCONNECT ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE TUBING REPEATEDLY SLIPPED OFF THE BARBS OF THE CENTRIFUGAL PUMP. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. 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 MM18

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK