BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PUMP MODEL 4P W/IO

    MDR report key: 137142 · Received December 5, 1997

    Report

    Report Number
    2921482-1997-00213
    Event Type
    Malfunction
    Date Received
    December 5, 1997
    Date of Event
    October 29, 1997
    Report Date
    October 29, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BEARING ON THE PUMPING CAM GOT LOOSE OVER TIME AND RUBBED AGAINST THE PIVOT ARM. THIS ACTION CAUSED THE ARM TO NOT FUNCTION PROPERLY AND RESULTED IN UNDERDELIVERY. THE DEVICE WAS MFG 1/1992 AND THE PROBLEM WAS AN UNUSUAL EVENT. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 1

    UNDERDELIVERY REPORTED. THE PUMP WAS SENT TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH A REPORT THAT "IT WILL NOT STOP BEEPING WHILE IN USE." THE NATURE OF THE ALARM WAS NOT SPECIFIED. DURING TESTING, ENGINEERS NOTED THAT THE PUMP WAS UNDERDELIVERING. WITH AN EXPECTED/DISPLAYED VOLUME OF 20ML, THE PUMP DELIVERED 16.5ML. NO REPORT OF ANY ADVERSE PT EVENT. NO FURTHER INFO WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other