BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM XLM W/MODIFD B

    MDR report key: 2950312 · Received February 6, 2013

    Report

    Report Number
    9615050-2013-00203
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 10, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.3 ML FROM AN UNEXPECTED DELIVERY OF 20 ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF (B)(4). BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE TECHNOLOGY OF THE PLUM XLM LIST #11859 DOES NOT CONTAIN A PUMP HISTORY THAT PROVIDES PAST PROGRAMMING SETTINGS. HOSPIRA IS UNABLE TO CONFIRM IF THE DEVICE WAS PROGRAMMED TO DELIVER AT A RATE OF 10 ML/HR AS REPORTED BY THE CUSTOMER. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT REC'D MORE MEDICATION THAN INTENDED. THE CUSTOMER CONTACT INDICATED THE PT WAS ADMITTED TO THE EMERGENCY ROOM WITH UNCONTROLLED ATRIAL FIBRILLATION. THE PHYSICIAN ORDERED A 10 MG CARDIZEM BOLUS, TO BE FOLLOWED BY A CONTINUOUS INFUSION OF 10 MG/HR. AT 1930, THE PT'S HR WAS REPORTED AS 76 BPM, AND BLOOD PRESSURE (BP) AS 109/52 MMHG. AT 1941, THE DEVICE WAS PROGRAMMED TO DELIVER A 100 ML CONTAINER OF CARDIZEM 10 MG/2 ML, AT A RATE OF 10 ML/HR, FOR A DURATION OF 10 HRS, AND THE DELIVERY WAS STARTED. AT 2000, THE CUSTOMER CONTACT REPORTED THE PT'S HR WAS 55 BPM, A BP WAS 59/35 MMHG. AT APPROX 2026, IT WAS REPORTED THAT THE DEVICE ALARMED "INFUSION COMPLETE." AT THAT TIME, THE NURSE NOTED THAT THE CONTAINER OF CARDIZEM WAS EMPTY. THE PHYSICIAN WAS NOTIFIED. AT 2035, THE PT'S HR WAS REPORTED AS 55 BPM, AND BP AS 49/30 MMHG. AT 2042, THE PT WAS TREATED WITH GLUCAGON 3 MG IV, CALCIUM CHLORIDE 100 MG IVP, AND AN UNSPECIFIED FLUID BOLUS. AT 2100 THE PT'S HR WAS REPORTED AS 73 BPM AND BP AS 108/87 MMHG. AT 2202, THE PT WAS TRANSFERRED FROM THE EMERGENCY ROOM TO THE INTENSIVE CARE UNIT. THE CUSTOMER CONTACT REPORTED THE PT WAS DISCHARGED TO SKILLED CARE FACILITY ON (B)(6) 2013. AT AN UNSPECIFIED TIME, THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50985 PLUM XLM W/MODIFD B 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention CARDIZAEM, MFR UNK