BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2212915 · Received August 3, 2011

    Report

    Report Number
    2016493-2011-00456
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    October 25, 2010
    Report Date
    November 8, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: LOG REVIEW. RESULTS: PROGRAMMING ERROR. THE CUSTOMER'S REQUEST FOR A LOG REVIEW HAS BEEN COMPLETED. A REVIEW OF THE EVENTS LOGGED IN THE ASSOCIATED PC UNIT EVENT LOG INDICATES THAT THE INITIAL OXYTOCIN DRUG SELECTED BY THE USER (DRUG ID 264) HAD A PRESET CONCENTRATION OF 20 UNITS/1000ML (20 MILLIUNIT/ ML) WITH THE DOSE TO BE ADMINISTERED PRESET AT 2 MILLIUNIT/MIN WHICH CALCULATED TO A RATE OF 6 ML/HR. THE FINAL OXYTOCIN DRUG SELECTED, HOWEVER, WAS A CUSTOM CONCENTRATION (DRUG ID 265) IN WHICH THE USER ENTERED THE CONCENTRATION AS 2 UNITS/1000ML (2 MILLIUNIT/ML). THE DOSE FOR THIS DRUG SELECTION IS ALSO PRESET AT 2 MILLIUNIT/ML WHICH, BASED ON THE CUSTOM CONCENTRATION ENTERED, CALCULATED TO A RATE OF 60 ML/HR. IT SHOULD BE NOTED THAT THE USER DID RECEIVE A GUARDRAILS WARNING, AFTER ENTERING THE CUSTOM CONCENTRATION PARAMETERS THAT THE CONCENTRATION WAS TOO LOW, HOWEVER, PROCEEDED WITH THE INFUSION AS PROGRAMMED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT WAS DETERMINED TO BE A USER PROGRAMMING ERROR.

    Description of Event or Problem · 1

    INITIAL REPORT WAS MADE BY PHARMACIST WHO REQUESTED DRUG ID INFO. PHARMACIST STATED THAT ORDER WAS FOR OXYTOCIN 5MCG/MIN AND A PHYSICIAN SAID IT WAS RUNNING AT 5 TIMES THE RATE. NO EVENT DETAILS WERE PROVIDED AT THIS TIME. SEVERAL MONTHS LATER, CUSTOMER PROVIDED EVENT DETAILS AND LOGS FOR REVIEW. EVENT DETAILS ARE AS FOLLOWS: PT WAS RECEIVING OXYTOCIN 20 UNITS IN 1000ML OF D5 1/2NS INFUSION AT 6ML/HOUR. INFUSION WAS TEMPORARILY DISCONTINUED DURING INSERTION OF EPIDURAL CATHETER FOR LABOR EPIDURAL. AT 13:50, OXYTOCIN INFUSION WAS RESTARTED AT 6ML/HR. FIVE MINS LATER, A PROLONGED DECELERATION STARTED; PHYSICIAN WAS NOTIFIED AND RESPONDED IMMEDIATELY. PT HAD TACHYSYSTOLE AND OXYTOCIN WAS NOTED BY PHYSICIAN AND NURSE TO BE INFUSING AT 60ML/HR. OXYTOCIN WAS IMMEDIATELY DISCONTINUED AND PT WAS BOLUSED WITH MAIN IV RINGERS LACTATE. PT WAS FULLY DILATED AND RUSHED TO DELIVERY. BABY WAS DELIVERED AND GIVEN AN APGAR SCORE OF 9/10.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention EPIDURAL CATHETER: MODEL/LOT# UNK| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)