BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER CPB SUPPORT SYSTEM

    MDR report key: 2004129 · Received February 24, 2011

    Report

    Report Number
    3003793891-2011-00001
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    RAND S.R.L.
    Product Code
    DTQ
    PMA / PMN Number
    K052555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS: THIS UNIT WAS SERVICED IN THE FIELD. TROUBLESHOOTING REVEALED NO PROBLEMATIC COMPONENTS AND THE ISSUE COULD NOT BE DUPLICATED. A TEST OF THE POTENTIOMETER, EXTERNAL DRIVE MOTOR, AND EMERGENCY FUNCTIONS YIELDED NORMAL RESULTS. THE UNIT WAS THEN TESTED/CALIBRATED/ADJUSTED AND CLEANED. NO REPAIR WAS NECESSARY. IN ADDITION TO SERVICING, THE PERFORMER LOG WAS ANALYZED. BASED ON THE DESCRIPTION OF THE EVENT AND THE LOG DATA, THERE WAS NO EVIDENCE OF A SYSTEM MALFUNCTION. THE ARTERIAL LINE PRESSURE INCREASED RAPIDLY FOR SOME REASON CAUSING MULTIPLE OVERPRESSURE ALARMS AND SUBSEQUENT BIOPUMP COAST EVENTS. THE ERROR LOG DOES NOT RECORD WHEN A USER MAY ATTEMPT TO GO INTO EMERGENCY MODE, SO IT WAS UNABLE TO DETERMINE WHY THE UNIT DID NOT RESPOND WHEN EMERGENCY MODE WAS ATTEMPTED. CONCLUSION: THIS DEVICE WAS EVALUATED AND THE ALLEGED FAILURE COULD NOT BE DUPLICATED. AT THIS TIME, THE CAUSE OF THE EVENT IS UNK. FURTHER INVESTIGATION AND DEVICE HISTORY REVIEW IS PENDING. UPON ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT DURING BYPASS, THIS PERFORMER PUMP WORKED WITHOUT INCIDENT FOR TWO HOURS. THE CLAMP WAS REMOVED AND THE ECG CONFIRMED THE BEATING HEART. FLOW WAS 4.6 L/MIN, BLOOD PRESSURE 60, ARTERIAL LINE PRESSURE 235 MM/HG. THE PERFUSIONIST REDUCED FLOW SO THE SURGEON COULD REMOVE THE VENT. WHEN THE PERFUSIONIST WENT TO INCREASE THE FLOW TO 3.5 L/MIN, THE ARTERIAL LINE PRESSURE ALERT (SET POINT 350 MM/HG) WENT OFF. THE FLOW WAS REDUCED AND THE ALARM ACKNOWLEDGED. WITHIN SECONDS, THE LINE PRESSURE ALARMED AGAIN (SET POINT 400 MM/HG). THE BIOPUMP WENT INTO COAST MODE, AND THE ALARM WAS AGAIN ACKNOWLEDGED. THE FLOW READING AT THIS TIME WAS LESS THAN 1 L/MIN. THE RPMS WERE INCREASED, BUT THE LINE PRESSURE ALARM WENT OFF AGAIN EVEN WITH THE SET POINT AT THE MAXIMUM LEVEL. COAST MODE CONTINUED, THEREFORE, EMERGENCY MODE WAS ATTEMPTED WITH NO RESPONSE. THE PERFUSIONIST CLAMPED THE VENOUS LINE. FLOW WAS STILL AT NEAR ZERO AND THE RESERVOIR WAS FULL. THE INPUTS INTO THE PUMP SUCH AS THE FLOW TRANSDUCER AND PRESSURE DOME WERE REMOVED, AND THE "HOME" BUTTON WAS PRESSED MULTIPLE TIMES. THE PERFORMER WENT BACK TO THE START UP SCREEN, AND FORWARD FLOW WAS ESTABLISHED AND CONFIRMED AS VOLUME DECREASED FROM THE RESERVOIR. THE LOW FLOW CONDITION OCCURRED FOR APPROX THREE MINS AT 36.5C. ADDITIONAL INFO WAS RECEIVED THAT THE PT WAS RECOVERING PER USUAL COURSE FOLLOWING SURGERY.

    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 UNK Life Threatening| R