BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON STER XCOAT DELPH PUMP

    MDR report key: 5054127 · Received September 3, 2015

    Report

    Report Number
    1124841-2015-00248
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 21, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE 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. THE FORWARD FLOW WAS OBSERVED TO BE NORMAL AND SUFFICIENT DURING THIS TEST, WITH NO ANOMALIES NOTED. 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 FOR THE WHINING NOISE WAS CONFIRMED, ALTHOUGH THE ISSUE WITH THE FLOW WAS NOT 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 NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, 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 JUST PRIOR TO CARDIOPULMONARY BYPASS, THEY EXPERIENCED NO FLOW FROM THE CENTRIFUGAL PUMP AND HEARD A WHINING NOISE. THE PUMP MOTOR WAS SET AT 1500 RPM FOR A NUMBER OF MINUTES WITH THE CIRCUIT CLAMPED IN A NO FLOW STATE. DURING THIS TIME, THE CPB CIRCUIT LINES WERE HANDED UP TO THE STERILE FIELD. THE AORTIC CANNULA WAS PLACED, SECURED, AND DE-AIRED IN PREPARATION FOR CONNECTION TO THE ARTERIAL LINE OF THE CPB CIRCUIT. DURING THE CONNECTION PROCESS, THE PUMP MOTOR SPEED WAS DECREASED TO 1200 RPM AND THE ARTERIAL LINE WAS UNCLAMPED IN ORDER TO SLOWLY ADVANCE THE PRIME FLUID AS THE CONNECTION TO THE CANNULA WAS ATTEMPTED. NO FORWARD FLOW WAS ESTABLISHED AT THE 1200 RPM AND A WHINING NOISE WAS OBSERVED FROM THE PUMP. THE PUMP HEAD WAS REMOVED FROM THE MOTOR AND RE-ATTACHED. THE MOTOR WAS RE-STARTED AT 1200 RMP, AND AGAIN, NO FORWARD FLOW WAS OBSERVED WHILE THE WHINING NOISE WAS HEARD. IT IS BELIEVED THAT THE PUMP MAY HAVE BEEN DAMAGED FROM RUNNING AT 1500 RPM FOR A PERIOD OF TIME WITH NO FLOW. THE PUMP HEAD AND MOTOR WERE BOTH CHANGED OUT AS THE CASE WAS AN AORTIC ARCH REPAIR WITH PLANNED DEEP HYPOTHERMIC CIRCULATORY ARREST. THE CHANGE OUT OF THE PRODUCTS CAUSED A 10 MINUTE DELAY, DURING WHICH THE PATIENT WAS STABLE. NO ISSUES WERE OBSERVED DURING CPB AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584141 BULK NON STER XCOAT DELPH PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ164275X TD23

    Patients

    Seq Age Sex Outcome Treatment
    1