BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 10894030 · Received November 24, 2020

    Report

    Report Number
    10894030
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 20, 2020
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A DEXTROSE 10% (D10) MEDICATION RUNNING THROUGH A LEFT-ARM PERIPHERAL IV (PIV) AT 5.7 ML/HR PER ORDERS. D10 FLUIDS STARTED. AFTER DISCUSSING WITH NEONATAL NURSE PRACTITIONER (NNP), ANOTHER ACCU-CHECK WOULD BE OBTAINED 1.5 HRS LATER. ONCE FLUIDS STRUNG, FLUID LEVEL IN BAG ABOVE THE "50" LINE. PREVIOUS ACCU-CHECKS BEFORE IV FLUIDS HAD BEEN STABLE AT 64 AND 45. WHEN ACCU-CHECK OBTAINED, IT READ "HIGH". THIS RN RECHECKED, AND IT AGAIN SAID "HIGH". NNP'S CALLED AND ORDERED TO TRY SECOND ACCU-CHECK MACHINE, WHICH ALSO READ "HIGH" A FEW MINUTES LATER. IV FLUIDS IMMEDIATELY STOPPED AND ENTIRE IV PUMP SYSTEM TURNED OFF. NNPS AT THE BEDSIDE. SERUM GLUCOSE OBTAINED IMMEDIATELY AND SENT TO LAB AT APPROXIMATELY 10 MINUTES LATER. D10 BAG WAS AT THE "150" LINE ON THE BAG AT THIS TIME. THIS NURSE HAD TO RUN EXTRA FLUID THROUGH THE TUBING WHEN STRINGING LINES IN ORDER TO CLEAR AIR BUBBLES, BUT NOT ENOUGH THAT THE FLUID WOULD BE AT THE "150" LINE AT THIS TIME. AFTER IV PUMP SYSTEM TURNED OFF, FLUID WAS STILL SEEN DRIPPING INTO RESERVOIR CHAMBER BELOW WHERE BAG IS SPIKED, AND THE FLUID LEVEL WAS SLIGHTLY BELOW THE "150" LINE ON THE BAG. BOTH ROLLER AND TRI-SET PORT CLAMPED, AND IV TUBING REMOVED FROM PATIENT. PIV SALINE LOCKED. NNP AT BEDSIDE FOR THIS. DIAPERS WEIGHED FROM 2ND CARE VISIT. THE PATIENT URINATED DURING THE DIAPER CHANGE SO TWO DIAPERS WERE USED. THE FIRST DIAPER WEIGHED 14G AND THE SECOND WEIGHED 30G. NNPS UPDATED ON THIS. 20 MINUTES LATER, LAB RESULTS WERE STILL NOT INPUT IN POWERCHART. CALLED LAB AGAIN REGARDING THIS. LAB RESULTS CALLED TO NICU AND CALLED TO NNP. SERUM GLUCOSE WAS CRITICAL AT 971. PATIENT'S VITALS STABLE AND MONITORING AND RN AT BEDSIDE. MOTHER UPDATED IN HER MOTHER-INFANT UNIT ROOM BY NNPS. APPROXIMATELY 10 MINUTES LATER, SERUM GLUCOSE AND ELECTROLYTES DRAWN PER NNP AND SENT TO LAB. DIAPER CHANGED AT THIS TIME AND WEIGHED 15G. CRITICAL SODIUM OF 128 AND CRITICAL GLUCOSE OF 645 CALLED TO NICU FROM LAB. THESE RESULTS WERE CALLED TO NNP. PATIENT'S VITALS AND STATUS STABLE. THIS RN AT BEDSIDE AND MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360689 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other