BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PUMP MODEL 4 W/RS 485

    MDR report key: 134294 · Received November 21, 1997

    Report

    Report Number
    2921482-1997-00209
    Event Type
    Injury
    Date Received
    November 21, 1997
    Date of Event
    October 3, 1997
    Report Date
    October 22, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABBOTT SPAIN AFFILIATE REPORTS THAT THE CUSTOMER INFORMED THEM OF A USER ERROR IN SETTING THE INFUSION RATE FOR THE DEVICE. THE PUMP WAS TESTED AT THE INTERNATIONAL TESTING CENTER. ABBOTT IRELAND FINISKLIN. THE PUMP PASSED PERFORMANCE VERIFICATION TESTING. IT WAS RECEIVED WITH A "LOOSE PART/ASSEMBLY" (FLOW DETECTOR) WHICH WAS NOT RELATED TO THE EVENT. THE FREQUENCY OF DEATH OR SERIOUS INJURY REPORTS FOR CODE 102 (OVERDELIVERY) FOR LIFECARE MODEL 4 PRODUCTS IS 0.58/MILLION SETS.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE ABBOTT SPAIN AFFILIATE STATES: "THE COMPLAINANT EXPLAINED TO US THAT THEY DIDN'T DOSIFY THE DRUG AT THE APPROPRIATE FLOW WHILE IT WAS CONNECTED TO THE PT." THE CUSTOMER INDICATES SETTING THE PUMP AT THE INCORRECT RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PUMP MODEL 4 W/RS 485 INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| R