BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL3 PLS MIC/MAC

    MDR report key: 2152332 · Received June 23, 2011

    Report

    Report Number
    9615050-2011-00449
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 24, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, THE PT RECEIVED MORE MEDICATION THAN INTENDED. THE PT WAS BEING TREATED FOR AN EMERGING MYOCARDIAL INFARCTION AND WAS RECEIVING HEPARIN THERAPY PRIOR TO A CARDIAC CATHETERIZATION PROCEDURE. AT 0636, CHANNEL 1 OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF HEPARIN IN 250ML, AT A RATE OF 20ML/HR, AND DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER 20 MINS, THE DEVICE ALARMED FOR "AIR IN LINE." AT THIS TIME, THE NURSE NOTED THE HEPARIN CONTAINER WAS EMPTY. THE PHYSICIAN WAS NOTIFIED. AT 0840, A PARTIAL THROMBOPLASTIN TIME (PTT) WAS DRAWN WITH RESULTS REPORTED AS 250 SECONDS. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CARDIAC CATHETERIZATION WAS PERFORMED AS SCHEDULED. NO MEDICAL INTERVENTIONS WERE REQUIRED. AT 1800, A PTT WAS DRAWN WITH RESULTS REPORTED AS 34 SECONDS. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED, INCLUDING IF THE HEPARIN THERAPY WAS DISCONTINUED OR RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XL3 PLS MIC/MAC 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR