BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER CPB SUPPORT SYSTEM

    MDR report key: 1705559 · Received May 26, 2010

    Report

    Report Number
    3003793891-2010-00001
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    April 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    RAND S.R.L.
    Product Code
    DTQ
    PMA / PMN Number
    K052555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS: NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS. UNIT LOGS WERE REVIEWED AND ANALYZED. CONCLUSION: BASED ON THE PROVIDED LOG AND EVENT DESCRIPTION, AFTER THE PUMP STOPPED DUE TO THE LOW LEVEL ALARM AND THE CLAMP CLOSED DUE TO BACKFLOW, THE CUSTOMER COULD NOT RESTART THE PUMP BECAUSE THE LOW LEVEL ALARM WAS CONSTANTLY ACTIVE. IT APPEARED THAT THE CUSTOMER THOUGHT THEY WERE DISABLING THE LOW LEVEL ALARM WHEN IN FACT THEY WERE ACKNOWLEDGING IT. EACH TIME THE ALARM WAS ACKNOWLEDGED, IT WOULD REACTIVATE (LIKELY DUE TO LOW RESERVOIR LEVEL). THIS SHOWED UP AS REPEATED A202 ENTRIES IN THE LOG. SINCE THE CUSTOMER HAD CONFIGURED THE PUMP TO STOP IF THE LOW LEVEL ALARM WAS ACTIVE THEY COULD NOT RESTART THE PUMP, AND BECAUSE THE MOTOR WAS STOPPED, THEY COULD NOT OPEN THE CLAMP (RPM MUST BE GREATER THAN 2200 TO OPEN THE CLAMP). AFTER GOING ON HAND CRANK THE RESERVOIR LEVEL CAME BACK UP, THE LOW LEVEL ALARM CLEARED, AND THE CUSTOMER WAS ABLE TO GET RPM>2200 TO DEACTIVATE THE CLAMP (FOR THE REST OF THE CASE). ACCORDING TO THE LOG DATA, FLOW WAS STOPPED FOR ABOUT 2 MINUTES AND HAND CRANK WAS PERFORMED FOR LITTLE OVER 2 MINUTES. FROM THE LOG, IT APPEARED THAT THIS UNIT FUNCTIONED AS DESIGNED, AND THE CUSTOMER HAD A PERSISTENT LOW LEVEL SITUATION THAT PREVENTED THEM FROM RESTARTING THE PUMP. THEREFORE, IT HAS BEEN CONCLUDED THAT OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THAT WHEN FILLING UP THE HEART OF THE PATIENT DURING THE SURGERY (ON REQUEST OF THE SURGEON), THE LEVEL ALERT WAS DEACTIVATED TO BE ABLE TO FILL THE HEART AS MUCH AS NEEDED. THE BLOOD LEVEL WENT BELOW THE LEVEL ALARM SENSOR (+/-300 ML LEVEL). THE CENTRIFUGAL PUMP STOPPED, BACKFLOW OCCURRED AND THE ARTERIAL CLAMP WAS CLOSED. THIS SEQUENCE WAS NORMAL AS THE SYSTEM WAS SET-UP LIKE THIS. UNFORTUNATELY, THE ARTERIAL FLOW COULD NOT BE ACTIVATED AGAIN. THE FLOW KNOB WAS TURNED TO ZERO RPM'S FOR 2 SECONDS, THEN INCREASED UP TO 2200 RPM'S, BUT THE ARTERIAL CLAMP DID NOT OPEN. THE RED AUTOCLAMP BUTTON ON THE MAIN SCREEN WAS PRESSED. AFTER DOING THIS PROCEDURE A FEW TIMES WITHOUT SUCCESS, THE DECISION WAS MADE TO TAKE THE ARTERIAL TUBING OUT OF THE CLAMP. WHEN TRYING TO RE-ESTABLISH THE FLOW AGAIN THE OBSERVATION WAS THAT THE ARTERIAL PUMP COULD NOT BE RE-STARTED. AT THAT MOMENT THE DECISION WAS TAKEN TO USE THE HAND CRANK TO SUPPORT THE PATIENT. WHILE FLOW AND PRESSURES WERE RE-ESTABLISHED MANUALLY THERE WAS MORE TIME TO TAKE A CLOSER LOOK AT THE SCREEN. THE LEVEL SENSOR ALARM WAS STILL ACTIVATED, ALTHOUGH >1500 ML OF BLOOD WAS IN THE VENOUS RESERVOIR. THE LEVEL ALARMS WERE DISABLED AND THE CENTRIFUGAL PUMP STARTED AGAIN. THE PATIENT WAS MOVED BACK TO THE CENTRIFUGAL PUMP OF THE PERFORMER'S EXTERNAL DRIVE UNIT AND THE SURGICAL PROCEDURE COULD BE FINISHED WITHOUT ANY OTHER PROBLEM. THE ARTERIAL CLAMP WAS NOT ACTIVATED AGAIN DURING THE REST OF THE PROCEDURE AND AT THE END OF THE BYPASS, WHEN THE RESERVOIR LEVEL WENT BELOW THE ALARM LEVEL THE PUMP STOPPED AND WAS RE-STARTED AS USUAL. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMER CPB SUPPORT SYSTEM DTQ RAND S.R.L. R5100052 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention