BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATROL PUMP

    MDR report key: 2161878 · Received July 8, 2011

    Report

    Report Number
    1527460-2011-00044
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE REPORTED, LIST NUMBER 52034 IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 52036, THAT IS MARKETED DOMESTICALLY. IF ADDITIONAL INFORMATION/CLARIFICATION IS OBTAINED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    PER THE REPORTER, SITE NUTRITIONIST INDICATED NASOGASTRIC NUTRITION AT HOME TO A PT WHO PRESENTED ACUTE DESNUTRITION (MALNUTRITION), ON (B)(6), 2011. WHEN NURSE CONNECTED THE PUMP TO PT, IT DID NOT WORK PROPERLY (ALTHOUGH IT WAS CONNECTED TO POWER THE PUMP TURNED OFF MANY TIMES); CONSEQUENTLY, NUTRITIONIST DECIDED TO HOSPITALIZE THE PT TO RECEIVE NUTRITION AT THE HOSPITAL (INSTITUTION DID NOT HAVE ANOTHER PUMP TO LEND THE PT TO TAKE HOME).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R