BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ALARIS PC UNIT 8015

    MDR report key: 21113128 · Received January 8, 2025

    Report

    Report Number
    MW5164472
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    November 6, 2024
    Report Date
    January 7, 2025
    Manufacturer
    BD ALARIS/CAREFUSION 303, INC.
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    2134: VERBAL ORDERS FROM MD (MEDICAL DOCTOR) TO PUT IN ORDERS FOR MAG. A 6 GRAM BOLUS WITH A 2 GRAM MAINTENANCE DOSE. REGULAR DIET AND REINSERT A FOLEY CATHETER 2145: RN (REGISTERED NURSE) STARTS THE POSTPARTUM RECOVERY PERIOD 2150: RN LEAVES THE ROOM TO GET MAGNESIUM BAGS AND ANTIBIOTIC 2200: PRIMARY RN ENTERS THE ROOM TO CHECK PATIENTS BLEEDING AND START MAGNESIUM AND ANTIBIOTICS 2203: SECOND AND THIRD RN ENTER THE ROOM TO HELP SET UP MAGNESIUM DRIP 2207: 6 GRAM BOLUS OF MAGNESIUM IS SCANNED AND STARTED. VERIFIED WITH A SECOND RN PRIOR TO STARTING 2208: RN STAYS AT BEDSIDE TO ASSESS THE PATIENT'S LUNG SOUNDS, REFLEXES AND SYMPTOMS. RN EXPLAINS TO PATIENT SIGNS AND SYMPTOMS TO REPORT 2208-2228: RN CONTINUES TO STAND AT BEDSIDE TO MONITOR PATIENT 2223: PATIENT IS VOMITING AND PRIMARY RN ASKS A SECOND RN TO BRING ZOFRAN. PATIENT COMPLAINS OF FEELING HOT 0226: SECOND RN ENTERS THE ROOM 0228: MAG PAUSED 0229: PRIMARY RN AND SECOND RN VERIFYING THE PROGRAMMING OF THE PUMP AND THE RATE OF MAGNESIUM 2231: CHARGE RN ENTERS THE ROOM 2232: FOURTH RN ENTERS THE ROOM 2234: IV FLUIDS INCREASED TO 999 2243: O2 APPLIED TO PATIENT 2250: MD NOTIFIED OF EVENTS. SAYS TO DRAW A MAGNESIUM LEVEL THEN REDRAW AGAIN IN 4 HOURS 2306: RN GETS ORDERS FROM MD TO GIVE 1 GM OF CALCIUM GLUCONATE 2306: RN CONTINUES TO STAY AT BEDSIDE TO MONITOR PATIENT ORDER WAS PLACED FOR MAGNESIUM BOLUS AT 2135. IT WAS VERIFIED BY PHARMACY AT 2140. IT WAS REMOVED FROM THE PYXIS AT 2155. PER THE REPORTS THE RN SET THE PUMP UP AT 2206 FOR A MAGNESIUM BOLUS OF 6G OVER 30 MINS FROM THE 20G/500ML BAG WITH AN INFUSION RATE OF 300ML/HR AND VTBI OF 150ML. RATE VERIFIED BY SECOND RN AND PUMP STARTED. WHEN THE PUMP WAS STOPPED AT 2226 THE VOLUME INFUSED PER THE PUMP WAS 102.096 ML. 33-YEAR-OLD FEMALE GRAVDA 2 NOW PARA 1 DELIVERED AT 38.4 GESTATIONAL AGE. SHE DEVELOPED CHORIOAMNIONITIS DURING LABOR. THIS WAS AN IUI PREGNANCY. PT ALSO HAS A HISTORY OF HYPOTHYROIDISM AND HSV (HERPES SIMPLEX VIRUS) 1. PT WAS DIAGNOSED IMMEDIATELY POSTPARTUM WITH SEVERE PREECLAMPSIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422548 BD ALARIS PC UNIT 8015 PUMP, INFUSION FRN BD ALARIS/CAREFUSION 303, INC. 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention MAGNESIUM.