BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 12028415 · Received June 18, 2021

    Report

    Report Number
    1314492-2021-02292
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    April 16, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DATE OF THIS REPORT IN MDR FOLLOW UP #1 IS BEING CORRECTED FROM BLANK TO 06/23/2021.

    Additional Manufacturer Narrative · 0

    F2: IN THE INITIAL MDR IS BEING CORRECTED FROM ASKU TO BLANK AS THIS MDR IS NOT A USER FACILITY/IMPORTER REPORT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THIS EVENT TO THE FDA THROUGH MEDWATCH: MW5101149. THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED SPECTRUM PUMP WAS INVOLVED IN "IMPROPER SHUTDOWN" DURING THERAPY OF CONTINUOUS NOREPINEPHRINE PROGRAMMED AT 40 MCG/MIN. IT WAS REVIEWED IN THE HISTORY LOG THAT THE PUMP WAS RUNNING ON BATTERY POWER WHILE IT WAS CONNECTED TO AN ELECTRICAL OUTLET. IT WAS ALSO STATED THAT THE "NURSE NOTED A CHANGE IN THE PATIENT'S HEART RATE AND BLOOD PRESSURE; BOTH DECREASING". THE PUMP ALLEGEDLY GENERATED AN ALERT FOR IMPROPER SHUTDOWN THAT WAS "RECOGNIZED IMMEDIATELY" BY THE CLINICIANS, AND A DIFFERENT PUMP WAS USED TO CONTINUE INFUSION THERAPY. THE PATIENT'S HEART RATE AND BLOOD PRESSURE WERE STABILIZED "QUICKLY AFTER A DOSE OF EPINEPHRINE AND RESTART OF NOREPINEPHRINE CONTINUOUS INFUSION". A HISTORY LOG INDICATES: ¿PUMP ON ¿ PWR STAT: BATT; BATTERY LOW ALERT¿ GIVEN AND ONE MINUTE LATER ¿PWR STAT: BATT IMPROPER SHUTDOWN ALERT¿ GIVEN." CORRODED ELECTRICAL PINS AND BATTERY CONTACTS WERE ALSO NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922086 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EPINEPHRINE| NOREPINEPHRINE