BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP,INFUSOR WTH 3 SMART LABEL

    MDR report key: 15808166 · Received November 16, 2022

    Report

    Report Number
    1416980-2022-06276
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED MEDWATCH 5112643 FOR THIS EVENT. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS NOT RETURNED AND THE LOT 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 · 0

    IT WAS REPORTED THAT AN INFUSOR PUMP OVERINFUSED. THIS OCCURRED DURING A PERIPHERAL NERVE BLOCK WHILE ADMINISTERING REMIFENTANIL AND PROPOFOL. THE NURSE NOTIFIED THE REMIFENTANIL SYRINGE WAS MUCH EMPTIER THAN EXPECTED. THE PUMP WAS SET TO 0.2MCG/KG/MIN FOR TWENTY ONE MINUTES. IT THEN DECREASED TO 0.1MCG/KG/MIN FOR SIXTEEN MINUTES. THE INTENDED DOSE WAS 389MCG OF REMIFENTANIL, HOWEVER THE PUMP INFUSED 1400MCG. THERE WAS NO REPORT OF 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
    1416190 PUMP,INFUSOR WTH 3 SMART LABEL PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PROPOFOL| REMIFENTANIL