BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER CPB SUPPORT SYSTEM

    MDR report key: 791037 · Received November 22, 2006

    Report

    Report Number
    3003793891-2006-00003
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Report Date
    October 25, 2006
    Manufacturer
    RAND S.R.L.
    Product Code
    DTQ
    PMA / PMN Number
    k052555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H3 ANALYSIS: THE PUMP ROTATOR WAS REMOVED FROM THE INSTRUMENT AND REPLACED AT THE USER FACILITY. TESTING OF THE ROTATOR AT THE MANUFACTURER SHOWED THAT THE OCCLUSION FUNCTIONS AND DIMENSIONS WERE WITHIN SPECIFICATIONS. INVESTIGATION CONTINUES IN AN ATTEMPT TO REPRODUCE THE REPORTED INCIDENT AND INCLUDES MECHANICAL VERIFICATION OF THE PUMP HOUSING AND THE PUMP RACEWAY, TUBING THICKNESS AND DUROMETER DIFFERENCES, INSERT CONFIGURATIONS, AND CALIBRATION ISSUES. CONCLUSION: CURRENT INVESTIGATION CANNOT REPLICATE THE PROBLEM, AND NO CONCLUSIONS CAN BE DRAWN REGARDING THE EVENT. THERE WAS NO REPORTED COMPLICATION TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, ONE OF THE PUMPS USED FOR CARDIOPLEGIA (PM4) DID NOT OCCLUDE THE 1/8" LINE. AN INSERT WAS BEING USED SO THAT BOTH 1/4 AND 1/8" LINES COULD BE USED ON THE SAME PUMP. WHEN THE 1/8" LINE DID NOT OCCLUDE, THEY SWITCHED IT TO ANOTHER PUMP WHERE IT OCCLUDED SUCCESSFULLY. THERE WAS NO COMPLICATION TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention