BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER CPB SUPPORT SYSTEM

    MDR report key: 793610 · Received November 30, 2006

    Report

    Report Number
    3003793891-2006-00006
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    January 1, 2006
    Report Date
    November 1, 2006
    Manufacturer
    RAND S.R.L.
    Product Code
    DTQ
    PMA / PMN Number
    K052555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6: EVALUATION RESULTS CODE -OTHER: THE INVESTIGATION CONTINUES; NO FINAL RESULTS ARE AVAILABLE AT THIS TIME. H3 ANALYSIS: THE PUMP ROTATOR WAS REMOVED FROM THE INSTRUMENT AND REPLACED AT THE USER FACILITY. TESTING OF THE ROTATOR CONTINUES AND HAS NOT BEEN COMPLETED AT THIS TIME. 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 CONFIGURATION ISSUES. CONCLUSION: CURRENT INVESTIGATION CONTINUES, 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 DELIVERY (PM4) DID NOT OCCLUDE THE 1/8" LINE, RESULTING IN IMPROPER DELIVERY OF THE CRYSTALLOID COMPONENT OF THE CARDIOPLEGIA. 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, THE LINE WAS SWITCHED TO ANOTHER PUMP WHERE IT OCCLUDED SUCCESSFULLY. THERE WAS NO REPORTED 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