BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER CPB SUPPORT SYSTEM

    MDR report key: 824208 · Received March 2, 2007

    Report

    Report Number
    3003793891-2007-00001
    Event Type
    Injury
    Date Received
    March 2, 2007
    Date of Event
    February 1, 2007
    Report Date
    February 1, 2007
    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

    ANALYSIS: FURTHER INVESTIGATION OF THE UNIT AT THE HOSPITAL BY MEDTRONIC SERVICE DETERMINED THAT THE PUMPS HAD BEEN WORKING AS PROGRAMMED, PRIOR TO AND AFTER THE DISPLAY FROZE. THE MEMORY CARD WAS REMOVED FROM THE DEVICE, AND THEN RE-INSTALLED IN THE PUMP. THE DEVICE WAS THEN POWERED DOWN, AND AFTER WAITING 15 SECONDS, THE DEVICE WAS POWERED UP. ALL SYSTEMS CHECKED NORMAL, AND THE PUMPS/DISPLAY/FLOW READING OPERATED NORMAL. THIS ACTION WAS PERFORMED A FEW MORE TIMES WITH NO PROBLEMS EXPERIENCED. DUE TO CONCERNS OF RECURRENCE OF THE ISSUE, THE DEVICE WAS RETURNED TO MEDTRONIC FOR ANALYSIS. TO DATE, ANALYSIS ON THIS PRODUCT HAS NOT BEEN COMPLETED. CONCLUSION: REDUCED DEVICE PERFORMANCE OCCURRED AND WAS RELATED TO THE EVENT. ROOT CAUSE HAS YET TO BE DETERMINED AS ANALYSIS HAS NOT BEEN COMPLETED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT WHILE SETTING UP FOR A BYPASS PROCEDURE, THIS DEVICE DISPLAYED FAILED TO ILLUMINATE, AND A BOOT UP ERROR WAS DISPLAYED. THE DEVICE WAS REBOOTED, AND PASSED SELF TESTS. DURING THE BYPASS PROCEDURE, THE DISPLAY ON THIS MULTI-PUMP UNIT DID NOT FUNCTION CORRECTLY. WHILE THE BIO-PUMP APPEARED TO BE MOVING, NEITHER THE FLOWS OR SPEED WERE DISPLAYED. IT WAS REPORTED THAT 3 OF 4 ADDITIONAL PUMPS HAD STOPPED WORKING, WHILE THE 4TH PUMP PUMPED TOO FAST. THE INSTRUMENT ALARMS WERE SOUNDING APPROPRIATELY. AFTER 45 MINUTES OF USE, THE PERFUSIONIST ELECTED TO CHANGE OUT THE BIO-PUMP FOR A STAND-ALONE BIO-CONSOLE FOR THE REMAINDER OF THE PROCEDURE. CARDIOPLEGIA WAS DELIVERED BY HAND CRANKING THE APPROPRIATE PUMP, AND AN ADDITIONAL AIR DETECTION SYSTEM WAS UTILIZED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 YR Required Intervention