BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 8784680 · Received July 12, 2019

    Report

    Report Number
    1314492-2019-02325
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Report Date
    October 1, 2019
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K173084
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED ON AN UNKNOWN DAY IN (B)(6) 2019. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; 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 A SPECTRUM IQ INFUSION PUMP INFUSED TOO QUICKLY DURING THERAPY. DURING CHANGE OF SHIFT INTRAVENOUS DRIP HANDOFF AND SAFETY CHECK, REGISTERED NURSES (RN) NOTICED THE DEXMEDETOMIDINE BAG WAS COMPLETELY EMPTY. A NEW 250 ML BAG WAS RECENTLY HUNG BY ANOTHER STAFF RN ON UNIT. THIRTY MINUTES LATER, THE PREVIOUS RN AND THIS RN HAD NOTICED THE BAG WAS ALREADY EMPTY AND THE PUMP WAS ALARMING AIR IN LINE. THE SETTINGS WERE CHECKED AND CONFIRMED BY BOTH RN'S. THE SETTINGS ON THE PUMP WERE ALL CORRECT, DOSE OF 1.5 MCG/KG/HR, RATE OF 28.13 ML/HR HOWEVER THE WHOLE BAG WAS GONE. THE VOLUME ON THE PUMP STILL READ THERE WERE 204 ML LEFT. THE SIGMA PUMP MALFUNCTIONED, AND THE PATIENT RECEIVED 250 ML OF DEXMEDETOMIDINE OVER ABOUT A HALF HOUR. THE PATIENT¿S VITAL SIGNS WERE STABLE AND THE PHYSICIAN WAS NOTIFIED AND PATIENT WAS ASSESSED AT THE BEDSIDE. THERE WAS NO KNOWN PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577818 SPECTRUM IQ INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR