BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP HEADS

    MDR report key: 6085711 · Received November 8, 2016

    Report

    Report Number
    1124841-2016-00383
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION WAS PERFORMED ON THE ACTUAL SAMPLE UPON RECEIPT, DURING WHICH NO ANOMALIES WERE FOUND ANYWHERE ON THE DEVICE. A REVIEW OF THE DEVICE HISTORY REVEALED NO PRODUCTION RELATED ANOMALIES. THE SAMPLE WAS BUILT INTO A SALINE CIRCUIT AND THEN SET UP ON A SARNS DRIVE MOTOR. THE RPM WERE SET AT 900 AND RAMPED UP BY 300 RPM EVERY TEN MINUTES FOR ONE HOUR FOR A MAXIMUM OF 2400 RPM. DURING EACH INTERVAL, THE RETURNED SAMPLE WAS OBSERVED FOR ANY RUNNING SOUND ANOMALIES. NO SOUND ANOMALIES OR ABNORMALITIES WITH THE FUNCTIONALITY WERE OBSERVED DURING THE TEST. THE SQUEALING SOUND COULD NOT BE REPLICATED. THE ISSUE IS LIKELY DUE TO AN ABNORMAL INTERACTION BETWEEN THE SEAL ROTOR AND THE STATOR SURFACE. THE EVENT WAS NOT ABLE TO BE RECREATED; HOWEVER, THE COMPLAINT WAS CONFIRMED BASED ON INVESTIGATIONS OF PREVIOUS OCCURRENCES OF THIS KNOWN ISSUE. (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SET UP, THE DELPHIN PUMP HEAD WAS MAKING A NOISE. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SET UP. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737797 CENTRIFUGAL PUMP HEADS CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 164275 TG15

    Patients

    Seq Age Sex Outcome Treatment
    1