BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLD 110V L.A. REF

    MDR report key: 2802448 · Received October 18, 2012

    Report

    Report Number
    9615050-2012-01254
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING, DISTAL TO THE DEVICE WITH NO DEVICE ALARM. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT IMMEDIATELY POST CARDIAC CATHETERIZATION FOR STENT PLACEMENT, THE PATIENT WAS HEMODYNAMICALLY IMBALANCED AND FOR AN UNSPECIFIED LENGTH OF TIME WAS IN ASYSTOLE. AT THAT TIME, THE DEVICE WAS PROGRAMMED TO DELIVER A REPORTED 999ML BOLUS LACTATED RINGER, AT AN UNSPECIFIED RATE, AND THE DELIVERY WAS STARTED. AFTER THE BOLUS WAS COMPLETE, THE DEVICE WAS REPROGRAMMED TO DELIVER AT A RATE OF 200ML/HR AND THE DELIVERY WAS RESTARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THERE WERE FIVE TO SEVEN AIR BUBBLES, OF THAT WERE THREE TO FOUR MILLIMETERS IN LENGTH, SEPARATED BY TEN TO FIFTEEN CENTIMETERS OF FLUID, DISTAL TO THE CASSETTE. NO DEVICE ALARM WAS NOTED. IT WAS NOT SPECIFIED IF AIR REACHED THE PATIENT. IT WAS REPORTED THAT THE TUBING SET WAS REPRIMED WITH NO NEW AIR SEGMENTS NOTED AND THE DELIVERY WAS RESUMED. THE CUSTOMER CONTACT INDICATED THAT THE AIR PROBABLY ENTERED THE CASSETTE WHEN THE LACTATED RINGER CONTAINER WAS CHANGED AFTER THE BOLUS WAS COMPLETE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE PATIENT CONTINUED TO BE HEMODYNAMICALLY IMBALANCED AND EXPIRED. THE CUSTOMER CONTACT REPORTED THAT THE PHYSICIAN INDICATED THE CAUSE OF DEATH DUE TO CARDIOGENIC SHOCK. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XLD 110V L.A. REF 80 FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK