BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL PUMP

    MDR report key: 2313529 · Received October 14, 2011

    Report

    Report Number
    1527460-2011-00074
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 17, 2011
    Report Date
    September 17, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LZH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG EVENT ID: (B)(4). THE DEVICE REPORTED, LIST NUMBER (B)(4), IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER (B)(4), THAT IS MARKETED DOMESTICALLY.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN OVER-DELIVERY. THE AMOUNT HUNG WAS 1.5L, AND THE RATE WAS SET AT 100-125 ML/HOUR; HOWEVER, THE PUMP DELIVERED 220 ML/HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP LZH, PUMP, INFUSION ENTERAL LZH ABBOTT LABORATORIES 52034

    Patients

    Seq Age Sex Outcome Treatment
    1