BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON STER XCOAT DELPH PUMP

    MDR report key: 6109341 · Received November 17, 2016

    Report

    Report Number
    1124841-2016-00405
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 17, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO MANUFACTURING ANOMALIES. VISUAL INSPECTION WAS PERFORMED ON THE SAMPLE UPON RECEIPT, DURING WHICH NO ANOMALIES WERE NOTED ANYWHERE ON THE DEVICE. 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 NOISE WAS NOT ABLE TO BE REPLICATED ON THE COMPLAINT SAMPLE; HOWEVER, THE ISSUE EXPERIENCED BY THE CUSTOMER IS LIKELY DUE TO AN ABNORMAL INTERACTION BETWEEN THE SEAL ROTOR AND STATOR SURFACES. (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 DURING CARDIOPULMONARY BYPASS, THE DELPHIN PUMP BEGAN SQUEALING. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761412 BULK NON STER XCOAT DELPH PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 3ZZ164275X UG30

    Patients

    Seq Age Sex Outcome Treatment
    1