BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION SET

    MDR report key: 3051352 · Received April 10, 2013

    Report

    Report Number
    1527460-2013-00037
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TESTING AND INVESTIGATION RESULTS DID NOT CONFIRM THE COMPLAINT OF UNDER-DELIVERY. THE SET DELIVERED AT 100% ACCURACY, WHICH IS WITHIN SPECIFICATION. THE SET PRIMED, FUNCTIONED, AND DELIVERED CORRECTLY WHEN TESTED. IN ADDITION, THE BATCH HISTORY RECORD REVIEW WAS FOUND TO BE ACCURATE WITH NO ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    MFG. EVENT ID: #(B)(4). THE DEVICE REPORTED, LIST NUMBER S222, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY, WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 00086, THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    SAME CASE AS 1527460-2013-00036. THE REPORTER INDICATED 1500 ML OF FEED WAS HUNG AT A RATE OF 115 ML/HOUR FOR 14 HOURS; HOWEVER, AFTER 14 HOURS, NO FEED HAD BEEN DELIVERED AND THE PUMP DID NOT ALARM. THE PATIENT, WHO IS AN INSULIN DEPENDENT DIABETIC, BECAME UNRESPONSIVE, AND AN AMBULANCE WAS CALLED. THE STAFF CHANGED THE FEEDING SET AND FEEDING WAS RECOMMENCED. THE AMBULANCE STAFF MONITORED THE PATIENT, AND THE PATIENT WAS NOT TAKEN TO THE HOSPITAL. THE FEEDING SET WAS NEW AND PRIMED CORRECTLY PRIOR TO USE. UPON REVIEW OF THE PUMP AT THE FACILITY, NO ISSUES WERE FOUND AND THE FACILITY CONTINUED TO USE IT. THE FACILITY BELIEVES THIS WAS A CASE OF USE ERROR; HOWEVER, NO DETAILS WERE PROVIDED. THE PATIENT'S CONDITION WAS LISTED AS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149658 COMPANION SET KNT ABBOTT NUTRITION S222

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening