BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2111794 · Received May 25, 2011

    Report

    Report Number
    2016493-2011-00337
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOG REVIEW IS NOT COMPLETED. ATTEMPTS HAVE BEEN MADE TO OBTAIN DEVICES FOR FAILURE INVESTIGATION. A F/U REPORT WILL BE SUBMITTED AFTER FAILURE INVESTIGATION IS COMPLETED WITH LOG REVIEW. A F/U REPORT WILL BE SUBMITTED IF DEVICES REC'D.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVER INFUSION OF MAGNESIUM. PT ADMITTED IN PRE TERM LABOR. MAGNESIUM SULFATE STARTED AT 0730 AT AN OUTSIDE FACILITY PRIOR TO TRANSFER TO HOSP. PT REC'D A 4 GM BOLUS OF MAGNESIUM SULFATE OVER 30 MINUTES FOLLOWED BY A MAINTENANCE RATE OF 2 MG/HR (50MLS/HR) STARTING AT 0800. REC'D AT HOSP BETWEEN 1100-1145. EMS DOCUMENTATION INDICATES 25 MLS MAGNESIUM SULFATE ADMINISTERED IN ROUTE. UPON ADMISSION, OUTSIDE FACILITY IV FLUIDS AND TUBING WAS USED AND PLACED INTO ALARIS PUMP CHAMBERS. IV RATE WAS SET AT 50 ML/HR. NURSE NOTED RAPID DRIPPING OF FLUID IN CHAMBER, WHICH CAUSED HER TO SUSPECT A PUMP MALFUNCTION. WITHIN AN HOUR OF ADMISSION TO HOSP, PT EXHIBITED SIGNS AND SYMPTOMS OF MAGNESIUM SULFATE TOXICITY. MAGNESIUM SULFATE INFUSION WAS STOPPED AND CALCIUM GLUCONATE PER PROTOCOL WAS GIVEN AND PER MD ORDERS WHICH DID ALLEVIATE THE TOXICITY SYMPTOMS. EVENT LOGS REC'D; INVESTIGATION PENDING. DEVICES HAVE BEEN REQUESTED BUT NOT REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other ALARIS PC UNIT: SN (B)(4)