BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 3232294 · Received July 15, 2013

    Report

    Report Number
    1124841-2013-00137
    Event Type
    Other
    Date Received
    July 15, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. FOR THIS REASON, TERUMO REFERENCES EVALUATION CODES. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT TEN MINUTES INTO CARDIOPULMONARY BYPASS (CPB) SURGERY, THE ARTERIAL BLOOD FLOW RATE OF THE PATIENT DROPPED TO APPROXIMATELY 2.0 L/MIN. THE PERFUSIONIST CHECKED FOR KINKS IN THE CIRCUIT, WHILE THE CARDIOVASCULAR SURGEON CHECKED THE AORTIC CANNULA POSITIONING. THERE WAS NOT AN APPARENT CAUSE OF THE REDUCTION IN BLOOD FLOW. THE PUMP SPEED WAS INCREASED TO 3000 RPM, YET THE BLOOD FLOW REMAINED AT 2.0 L/MIN. THE PERFUSIONIST THEN ELECTED TO: COOL THE PATIENT FROM 32 DEGREE CELSIUS TO 25 DEGREE CELSIUS TO FURTHER REDUCE THE METABOLIC RATE; AND CHANGE OUT OF THE DRIVE MOTOR WHICH STOPPED THE ARTERIAL FLOW FOR APPROXIMATELY TWO MINUTES. WHEN THESE MEASURES FAILED, THE PERFUSIONIST THEN ELECTED TO SWITCH TO A ROLLER PUMP FOR ARTERIAL FLOW. THE FLOW WAS STOPPED, THE CENTRIFUGAL PUMP HEAD WAS REMOVED, AND A ROLLER PUMP BOOT WAS INSERTED INTO THE CIRCUIT. THERE WAS A BLOOD LOSS OF APPROXIMATELY 50 ML, AND THE TOTAL TIME OF REDUCED BLOOD FLOW WAS APPROXIMATELY TEN MINUTES. WHEN THESE MEASUREMENTS FAILED, THE PERFUSIONIST THEN ELECTED TO SWITCH TO A ROLLER PUMP FOR ARTERIAL FLOW. THE FLOW WAS STOPPED, THE CENTRIFUGAL PUMP HEAD WAS REMOVED, AND A ROLLER PUMP BOOT WAS INSERTED INTO THE CIRCUIT. THERE WAS A BLOOD LOSS OF APPROXIMATELY 50 ML, AND THE TOTAL TIME OF REDUCED BLOOD FLOW WAS APPROXIMATELY TEN MINUTES. THE BOOT WAS PRIMED, OCCLUSION WAS ADJUSTED, AND THE ARTERIAL FLOW WAS RE-INITIATED. BLOOD FLOW RATES WERE AT 4-5 L/MIN. THE REMAINDER OF THE PROCEDURE WAS WITHOUT ISSUE. THE PATIENT WAS WEANED FROM CPB, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT IN GOOD CONDITION. WITHIN FOUR HOURS OF SURGERY, THE PATIENT WAS AWAKE, ALERT, EXTUBATED, AND RESPONSIVE. AFTER THE PROCEDURE, THE PERFUSIONIST PLACED THE CENTRIFUGAL PUMP HEAD IN A MOCK CIRCUIT AND WAS ABLE TO GENERATE REASONABLE FLOW RATES AT DIFFERENT PUMP SPEEDS. THE PUMP HEAD APPEARED TO FUNCTION WHILE ON THE MOCK CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326668 SARNS CENTRIFUGAL PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. NA PM15

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention