BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8764012 · Received July 5, 2019

    Report

    Report Number
    2016493-2019-00750
    Event Type
    Death
    Date Received
    July 5, 2019
    Report Date
    June 10, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S EXPERIENCE OF A PROGRAMMING ISSUE WAS IDENTIFIED AS DUE TO USER PROGRAMMING. THE PCU EVENT LOG SHOWS A NEW DATASET WAS LOADED INTO THE PCU WHEN THE USER SELECTED NEW PATIENT AND THE USER WAS THEN PROMPTED TO SELECT A NEW PROFILE. THIS IS THE NORMAL BEHAVIOR WHEN A NEW DATASET HAS BEEN UPLOADED TO THE PCU AND THEN ACTIVATED BY THE USER SELECTING NEW PATIENT. THE DATASET RECEIVED LABELED EDH (B)(4) HAS OPTIONS FOR BOTH WEIGHT-BASED AND NON-WEIGHT BASED FOR NOREPINEPHRINE UNDER THE ADULT INPATIENT PROFILE. THE DATASET RECEIVED LABELED EDH (B)(4) ALSO HAS OPTIONS FOR BOTH WEIGHT-BASED AND NON-WEIGHT BASED FOR NOREPINEPHRINE UNDER THE ADULT INPATIENT PROFILE, HOWEVER THIS DATASET IS IN DRAFT STATUS AND IT IS UNKNOWN IF THIS IS THE ACTUAL DATASET THAT WAS LOADED WHEN THE USER SELECTED NEW PATIENT. THE DATASET THAT WAS IN USE ON (B)(6) 2019 WAS NOT RECEIVED FOR INVESTIGATION SO IT COULD NOT BE DETERMINED IF THE WEIGHT BASED OPTION FOR NOREPINEPHRINE WAS AVAILABLE. CHANGES TO THE DATASET AND/OR SELECTING AN INCORRECT PROFILE ARE MOST LIKELY THE REASON WHY THE USER WAS UNABLE TO FIND THE MEDICATION THAT THEY WERE USED TO OR EXPECTING TO SEE (WEIGHT-BASED VS. NON-WEIGHT BASED).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EMERGENCY ROOM RN TURNED ON THE ALARIS PCU FOR PROGRAMMING WHEN THE DEVICE ASKED IF THE PATIENT WAS A NEW PATIENT. "YES" WAS SELECTED, AND THE ADULT INPATIENT PROFILE WAS USED. AT THIS POINT, THE DEVICE INITIATED THE BEGINNING SCREEN THAT THE NURSE DID NOT RECOGNIZE, ASKING HER TO CHOOSE ONE OF THE FOLLOWING: ADULT INPATIENT, INFUSION CENTER, NEONATE, OR PEDIATRIC. THE NURSE SELECTED THE TOP BUTTON INDICATING ADULT INPATIENT. AT THE IV GUARDRAIL DRUG PROMPT, "N" WAS CHOSEN FOR NOREPINEPHRINE. THE DEVICE DID NOT PROMPT THE NURSE FOR NON-WEIGHT BASED VERSUS WEIGHT BASED DOSING; INSTEAD, THE DEVICE WENT DIRECTLY FROM THE DRUG LIBRARY SELECTION OF NOREPINEPHRINE TO THE CONCENTRATION PAGE OF 4MG/250ML, WITH THE WEIGHT BASED UNITS OF MCG/KG/MIN. THE NURSE BACKED OUT AND PERFORMED THE PROGRAMMING TASK AGAIN ONLY TO HAVE THE SAME RESULTS. THE DEVICE WAS THEN SHUT DOWN AND RESTARTED FROM THE BEGINNING. THE NURSE ADMITTED THAT DURING THE PROGRAMMING PHASE, SHE SELECTED THE PATIENT AS A "NEW PATIENT" WHICH CAUSED THE PREVIOUS SETTINGS TO BE ERASED. ALL OF THE DEVICES HAVE THE DEKALB DATA SET, WHICH HAD PROVIDED THE APPROPRIATE NON-WEIGHT BASED OPTION IN THE PAST. IT WAS ATTEMPTED TO DETERMINE IF THE EVENT WAS CAUSED BY USER ERROR, HOWEVER THE SCREEN COULD NOT BE RECREATED. IT WAS FURTHER STATED THAT THE PATIENT RECEIVED THE APPROPRIATE WEIGHT-BASED NOREPINEPHRINE DOSE, AND THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE PROGRAMMING OF THE DEVICE. THE CUSTOMER WAS INTERESTED TO SEE IF THE CORRECT LIBRARY WAS BEING USED, AS THEY SUSPECTED THE PUMP WAS NOT UPDATED WITH THE CORRECT FACILITY LIBRARY BUT NEED BD TO LOOK AT THE LOGS TO CONFIRM THIS. A "CODE BLUE" WAS APPARENTLY INITIATED AT AN UNSPECIFIED TIME AFTER THE NOREPINEPHRINE DOSE, AND THE PATIENT SUBSEQUENTLY EXPIRED. NO ADDITIONAL INFORMATION REGARDING THE DEATH OF THE PATIENT WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. DEVICE EVALUATED BY MANUFACTURER? NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EMERGENCY ROOM RN TURNED ON THE ALARIS PCU FOR PROGRAMMING WHEN THE DEVICE ASKED IF THE PATIENT WAS A NEW PATIENT. THE RN SELECTED ¿YES¿ AND THEN THE DEVICE ASKED IF THE PATIENT WAS AN ADULT INPATIENT, IN WHICH THE RN SELECTED ¿YES¿. AT THIS POINT, THE DEVICE INITIATED THE BEGINNING SCREEN THAT THE RN DID NOT RECOGNIZE ASKING HER TO CHOOSE ONE OF THE FOLLOWING: ADULT INPATIENT, INFUSION CENTER, NEONATE, OR PEDIATRIC. THE RN SELECTED THE TOP BUTTON INDICATING ADULT INPATIENT. AT THE IV GUARDRAIL DRUG PROMPT, THE RN CHOSE ¿N¿ FOR NOREPINEPHRINE. THE DEVICE DID NOT PROMPT THE RN FOR NON-WEIGHT BASED VERSUS WEIGHT BASED DOSING. INSTEAD, THE DEVICE WENT DIRECTLY FROM THE DRUG LIBRARY SELECTION OF NOREPINEPHRINE TO THE CONCENTRATION PAGE OF 4 MG/250 ML AND THE UNITS AS MCG/KG/MIN. THE RN BACKED OUT AND PERFORMED THE PROGRAMMING TASK AGAIN ONLY TO HAVE THE SAME THING OCCUR. AT THAT TIME, THE RN SHUT DOWN THE DEVICE AND STARTED FROM THE BEGINNING. THE RN WAS ABLE TO SEQUESTER THE DEVICE AND TUBING SETS AFTER THE CODE AND ONCE THE FAMILY AND ME LEFT THE ROOM. THE RN ADMITS THAT DURING THE PROGRAMMING PHASE, SHE SELECTED THE PATIENT AS A "NEW PATIENT" WHICH CAUSED THE PREVIOUS SETTINGS TO BE ERASED. ALL OF THE DEVICES HAVE THE DEKALB DATA SET USED IN THE ROOM AND HAVE PROVIDED THE APPROPRIATE NON-WEIGHT BASED OPTION IN THE PAST. THE RN ATTEMPTED TO DETERMINE IF THE EVENT WAS CAUSED BY USER ERROR BUT COULDN¿T RECREATE THE SAME SCREEN. THE RN FURTHER STATED THAT THE PATIENT RECEIVED THE APPROPRIATE WEIGHT-BASED NOREPINEPHRINE DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557207 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 8100| PRI TUBING,8015,THERAPY DATE UNKNOWN| PRI TUBING,8015,THERAPY DATE UNKNOWN