BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 15942183 · Received December 8, 2022

    Report

    Report Number
    1314492-2022-05293
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    November 3, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED PRODUCT IS AN UNKNOWN SPECTRUM INFUSION PUMP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION H6 AND H10: THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A DEFINITIVE CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED, HOWEVER THE PROBLEM DESCRIPTION MAY POTENTIALLY RELATED TO FA 2021-056, WHICH IS ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSIONS FOR SPECTRUM PUMPS, WHICH CAN CAUSE UNDER-INFUSIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT INFUSION OF MIDAZOLAM 15MG WITH AN UNKNOWN SPECTRUM PUMP, THE PATIENT DOSE WAS NOT DELIVERED. THE FLOW RATE WAS 900 ML/HR. IT WAS FURTHER REPORTED THAT THE PUMP SHOWED DELIVERY OF THE MEDICATION; HOWEVER, THE PATIENT DID NOT RECEIVE THE INTENDED DOSE TWO TIMES. A SECONDARY MEDICATION WAS DELIVERED TO STABILIZE THE PATIENT, SPECIFIED AS ¿CONTROL¿ THE SYMPTOMS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441585 NI PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention MIDAZOLAM| UNKNOWN SEDATIVE