BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 9355852 · Received November 21, 2019

    Report

    Report Number
    1314492-2019-04130
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 30, 2019
    Report Date
    January 3, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K173084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION H3, H6 AND H10: 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.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP EXPERIENCED MAX AIR ALARM IN LINE. BAXTER NURSE ROUNDING REPORTS NURSE WAS INFUSING PENICILLIN G AT 200 ML/HR, USING HIGH FLOW TUBING (PRODUCT CODE 2C8491). THE NURSE REPORTS AFTER 1 MINUTE THE PUMP ALARMED MAX ALARM IN LINE. THE NURSE WAS NOT ABLE TO DETECT A SIGNIFICANT AMOUNT OF AIR AND TRIED TO RUN THE INFUSION AGAIN. THE MAX AIR IN LINE ALARMED AGAIN AND CONTINUED TO ALARM. THE PUMP WOULD NOT STOP ALARMING MAX AIR. NURSE SWITCHED TO NEW PUMP AND RAN INFUSION WITH NO ISSUES. THE PROBLEM WAS FOUND DURING PATIENT INFUSION IN THE LABOR AND DELIVERY DEPARTMENT. THERE WAS PATIENT INVOLVEMENT BUT 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
    1149043 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 2C8491| 2C8491