BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATROL PUMP

    MDR report key: 2063734 · Received April 14, 2011

    Report

    Report Number
    1527460-2011-00028
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    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. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    SAME CASE AS 1527460-2011-00029 AND 1527460-2011-00030. THREE PUMPS PRESENTED THE SAME PROBLEM. THEY INDICATED LOW BATTERY AND NO FLOW ON THE DISPLAY EVEN THOUGH THEY WERE PLUGGED IN. AT THE TIME OF EVENT, THE SET AND THE TUBE WERE CHECKED AND HAD NO PROBLEM. THE HOSPITAL TESTED THE ELECTRICAL OUTLET WITH OTHER EQUIPMENT AND VERIFIED THERE WASN'T ANY PROBLEM WITH ELECTRICAL GRID. THE PROBLEM WAS WITH THE PUMPS. ONE PT WHO WAS HOSPITALIZED AT CARDIAC ICU DID NOT RECEIVE FEED FOR ALMOST 24 HOURS. THE FIRST PUMP WAS CONNECTED TO PT ON (B)(6) 2011 AND THE PROBLEM WAS VERIFIED DURING THE NIGHT. IN TOTAL, THE PT USED THREE PUMPS. THERE WAS NO BACK-UP PUMP FOR REPLACEMENT, SO THE FEED WAS NOT INFUSED BY OTHER MEANS, AND THE REPORTER DID NOT KNOW THE REASON.

    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 Other