BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER CPB SUPPORT SYSTEM

    MDR report key: 1463501 · Received August 28, 2009

    Report

    Report Number
    3003793891-2009-00002
    Event Type
    Injury
    Date Received
    August 28, 2009
    Date of Event
    July 31, 2009
    Report Date
    July 31, 2009
    Manufacturer
    RAND S.R.L.
    Product Code
    DTQ
    PMA / PMN Number
    K052555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE CLINICAL OBSERVATION WAS ABLE TO BE DUPLICATED/REPLICATED. AFTER DISCOVERING HOW THE PERFORMER WAS CONFIGURED FOR THE SPECIFIC PROCEDURE IN QUESTION (REVIEWED CASE FILE WITHIN DEVICE MEMORY), THE PERFORMER WAS FIXED IN THE LAB AT OUR OFFICE IN LIKEWISE FUNCTION. IT WAS CONFIGURED FOR THE SYSTEM TO PROVIDE A MESSAGE ONLY ALERT IF THE SYSTEM DETECTED AN AIR BUBBLE. MESSAGE ONLY MEANS THAT IN CASE OF AIR BUBBLE DETECTION, THERE WILL BE A MESSAGE (BOTH VISUAL AND AUDIBLE). MESSAGE ALSO MEANS THERE IS NO ARTERIAL PUMP (BIO PUMP) CHANGE IN SPEED. IN ORDER TO SIMULATE THE INCIDENT, THE BUBBLE DETECTOR/FLOW SENSOR FROM THE PERFORMER WAS DISCONNECTED. THE BIO PUMP STOPPED AND A VISUAL AND AUDIBLE "ABD CABLE NOT CONNECTED" ALARM SOUNDED, WHICH WAS THE SAME ALARM NOTED BY THE CUSTOMER. THE BIO PUMP WAS NOT ABLE TO BE STARTED UNTIL INITIATING EMERGENCY MODE. AFTER INITIATING EMERGENCY MODE, THE BIO PUMP WAS RESTARTED AND THE PUMP SPEED WAS REGULATED TO PREFERENCE. THE FIELD SERVICE TECHNICIAN VISITED THE ACCOUNT TO PERFORM ANALYSIS ON THE INSTRUMENT. VISUAL INSPECTION NOTED THE FLOW BOARD WAS DAMAGED. THE BOARD WAS REMOVED AND REPLACED, WHICH RESOLVED THE ISSUE. THE BOARD WAS RETURNED AND INSPECTED, WHICH NOTED A DAMAGED COMPONENT ON THE FLOW BOARD. POWER TO THE FLOW BOARD WAS MOST LIKELY DEGRADED OR LOST DUE TO THE DAMAGED COMPONENT. IT IS LIKELY THE MULTIPLE AUDIBLE AND VISUAL ALARMS, AS WELL AS THE NO FLOW CONDITION WERE DUE TO THE COMPONENT/ BOARD FAILURE. THE BOARD WAS FORWARDED TO THE MANUFACTURER FOR FURTHER ANALYSIS. CONCLUSION: FAILURE OF THE INSTRUMENT TO PERFORM AS INTENDED WAS ISOLATED TO A DAMAGED COMPONENT ON THE POWER BOARD. THE CLINICAL OBSERVATION WAS ABLE TO BE DUPLICATED IN THE LAB AND WAS ABLE TO BE RESOLVED WITHOUT THE HAND CRANK BY ENTERING EMERGENCY MODE. A REVIEW OF COMPLAINTS HAS NOT IDENTIFIED ANY TRENDS RELATED TO THIS ISSUE. THE PATIENT FULLY RECOVERED FROM THE PROCEDURE WITHOUT ANY ADVERSE EFFECTS. MEDTRONIC WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE TO DETECT SIMILAR EVENTS SHOULD THEY OCCUR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT LOSS OF FLOW WAS EXPERIENCED DURING THE BYPASS PROCEDURE. CARDIOPULMONARY BYPASS WAS INITIATED AND THE AIR BUBBLE DETECTOR WAS INITIATED WITH THE INSTRUMENT. APPROX 40 MINS LATER, THE AIR BUBBLE DETECTOR ALARM SOUNDED; NO AIR WAS PRESENT, SO THE ALARM WAS CLEARED. IMMEDIATELY THEREAFTER, THE ALARM SOUNDED AGAIN AND AGAIN. THE AIR BUBBLE DETECTOR WAS THEN DEACTIVATED. THE PATIENT WAS REWARMED AND THE FINAL DOSE OF CARDIOPLEGIA WAS INITIATED. APPROXIMATELY 30-40 SECONDS LATER, THE ARTERIAL PUMP STOPPED. THE "AIR BUBBLE CONNECTOR NOT CONNECTED" ALARM SOUNDED. THE ARTERIAL AND VENOUS LINES WERE THEN CLAMPED TO PREVENT FURTHER EXSANGUINATION OF THE PATIENT. THE CARDIOPLEGIA PUMP HAD STOPPED DUE TO THE ALARM CONDITION. A SECOND PERFUSIONIST WAS CALLED TO HELP AND ATTEMPTED TO ACTIVATE THE EMERGENCY MODE, BUT WAS UNSUCCESSFUL. THE HAND CRANK WAS THEN INITIATED WITH THE EXTERNAL DRIVE OF THE BIOHEAD. IT WAS NOTED THE PATIENT SUSTAINED A LACK OF PERFUSION FOR ABOUT 2 MINUTES AND THE BLOOD PRESSURE DROPPED FROM 60MMHG TO 20MMHG. A SECOND PERFUSIONIST WAS ABLE TO INITIATE EMERGENCY MODE AND THE BIOHEAD WAS RETURNED TO THE MAIN PUMP DRIVE AND HAND CRANKING WAS SUSPENDED. IN EMERGENCY MODE, THE PUMP WAS NOT GIVING A FLOW READING. THE PATIENT WAS WEANED FROM CPB WITHOUT DIFFICULTY. THE PATIENT REMAINED STABLE AND FULLY RECOVERED FROM THE PROCEDURE. THE INSTRUMENT WAS REMOVED FROM SERVICE.

    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