BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON STER XCOAT DELPH PUMP

    MDR report key: 5054022 · Received September 3, 2015

    Report

    Report Number
    1124841-2015-00247
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 20, 2015
    Report Date
    September 14, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON SEPTEMBER 3, 2015. (B)(4). THE ACTUAL SAMPLE WAS VISUALLY INSPECTED UPON RECEIPT AND NO ANOMALIES WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO PRODUCTION RELATED ANOMALIES. THE ACTUAL 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 ABNORMAL SOUNDS WERE DETECTED TO COME FROM THE DEVICE. THE SQUEALING SOUND COULD NOT BE REPLICATED. THE ISSUE IS LIKELY DUE TO AN ABNORMAL INTERACTION BETWEEN THE SEAL ROTOR AND THE STATOR SURFACE; THEREFORE, THE COMPLAINT WAS CONFIRMED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CENTRIFUGAL PUMP MADE A SQUEAKING NOISE. IT WAS ALSO OBSERVED THAT THERE WAS CONDENSATION INSIDE THE DEVICE. THE USER FACILITY MADE IT KNOWN THAT THE OR WAS VERY HUMID AND CONDENSATION WAS PRESENT WHEN THE SQUEALING OCCURRED. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586722 BULK NON STER XCOAT DELPH PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ164275X TG10

    Patients

    Seq Age Sex Outcome Treatment
    1