BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 10495342 · Received September 4, 2020

    Report

    Report Number
    1314492-2020-02950
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 4, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K173084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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 A SPECTRUM IQ PUMP DID NOT INFUSE DURING THERAPY (MEDICATION, DOSE, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). THE EVENT HAPPENED DURING PATIENT USE AT THE SURGICAL CARE UNIT (SCU) AND THE SET UP WAS IDENTIFIED AS NOT HAVING THE PROPER HEAD HEIGHT. THERE WAS NO 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
    957963 SPECTRUM IQ INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1