BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI-FLOW MODEL 4000 PLUS

    MDR report key: 196250 · Received November 6, 1998

    Report

    Report Number
    2921482-1998-00172
    Event Type
    Injury
    Date Received
    November 6, 1998
    Date of Event
    September 11, 1998
    Report Date
    October 6, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OVERDELIVERY REPORTED. THE PUMP WAS INITIALLY SET TO INFUSE A MAINTENANCE SOLUTION AT 50ML/H ON LINE A, A MAGNESIUM SULFATE LOADING DOSE OF 6G IN 250ML AT 500ML/H ON LINE B, AND PITOCIN (CONCENTRATION UNSPECIFIED) AT 6ML/H ON LINE C. THE MAGNESIUM SULFATE LOADING DOSE COMPLETED AS EXPECTED. THE PUMP WAS THEN SET ON LINE B TO INFUSE A MIXTURE OF MAGNESIUM SULFATE 20G IN 250 ML TO RUN AT 25ML/H. THE PT HAD BEEN UNCOMFORTABLE AND WAS EXPERIENCING NAUSEA THROUGHOUT THE DAY. THE PITOCIN HAD BEEN TITRATED UP FOR INDUCTION OF LABOR. A NURSE REPORTS THAT APPROX 30 MIN AFTER THE SECOND MAGNESIUM CONTAINER WAS HUNG, THE PT'S NAUSEA HAD INCREASED AND SHE WAS EXPERIENCING DRY HEAVES. IT WAS OBSERVED AT THAT TIME THAT THE SECOND CONTAINER WAS ALMOST EMPTY. THE PT PROGRESSIVELY BECAME LETHARGIC AND UNRESPONSIVE. SHE WAS GIVEN CALCIUM GLUCONATE, DOSAGE NOT SPECIFIED. OVER THE NEXT 2 TO 3 HRS THE PT'S LEVEL OF CONSCIOUSNESS RETURNED TO NORMAL; SHE DID NOT RECALL THE EVENT. THE PT RECOVERED AND LATER DELIVERED THE BABY WITHOUT INCIDENT. NO ADVERSE SEQUELAE TO THE PT OR BABY WERE OBSERVED. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-FLOW MODEL 4000 PLUS INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention OMNI-FLOW TUBING, LIST AND LOT NUMBERS UNK.