BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON STER XCOAT DELPH PUMP

    MDR report key: 4977161 · Received August 6, 2015

    Report

    Report Number
    1124841-2015-00221
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 6, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION, A VIDEO OF THE COMPLAINT SAMPLE SQUEALING DURING PRIME WAS PROVIDED. THE VIDEO SHOWS THE PUMP REPEATEDLY SQUEALING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. IN ADDITION, A RETENTION SAMPLE FROM THE SAME PRODUCT CODE/LOT COMBINATION AS THE ACTUAL SAMPLE WAS OBTAINED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED ON THE RETENTION SAMPLE, DURING WHICH NO ANOMALIES WERE FOUND ANYWHERE ON THE DEVICE. THE RETENTION SAMPLE WAS SET UP ON A SARNS DRIVE MOTOR BUILT INTO A SALINE CIRCUIT. 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 SAMPLE WAS OBSERVED FOR ANY RUNNING SOUND ANOMALIES. NO ABNORMALITIES WERE DETECTED COMING FROM THE DEVICE. THE SQUEALING SOUND COULD NOT BE REPLICATED. THIS IS A KNOWN ISSUE AND IS LIKELY DUE TO AN ABNORMAL INTERACTION BETWEEN THE SEAL ROTOR AND THE STATOR SURFACE. THE COMPLAINT WAS CONFIRMED. (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 SYSTEMS CORPORATION THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A VERY HIGH PITCHED SQUEAL COULD BE HEARD FROM THE CENTRIFUGAL PUMP. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519390 BULK NON STER XCOAT DELPH PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ164275X TE02

    Patients

    Seq Age Sex Outcome Treatment
    1