BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARD

    MDR report key: 1828511 · Received September 1, 2010

    Report

    Report Number
    MW5017307
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 1, 2010
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT IS RECEIVING TPN FOR 12 HOURS DAILY VIA AMBULATORY PUMP BODYGUARD. TWO BAGS WERE SENT TO PT WITH TUBING PRIMED AND ALL AIR REMOVED. PT RECEIVED BAGS AND STORED THEM IN THE REFRIGERATOR AS INSTRUCTED. DURING INFUSION OF FIRST BAG, FILTER OCCLUDED AND PUMP ALARMED WITH MESSAGE THAT THERE WAS AIR IN LINE. ON-CALL NURSE WAS ABLE TO TROUBLESHOOT AND INSTRUCT PT -WITH MANY MANIPULATIONS- HOW TO REMOVE AIR IN TUBING AND INFUSION WAS COMPLETED. AT TIME OF INFUSION OF SECOND BAG, PT REMOVED BAG FROM REFRIGERATOR AND NOTICED THAT BAG HAD A VERY NOTICEABLE QUANTITY OF AIR INSIDE. BAG WAS NOT INFUSED. THIS ISSUE HAS OCCURRED BEFORE -WITH DIFFERENT LOT NUMBERS- AND AIR SEEMS TO BE INTRODUCED INTO SYSTEM BY THE 1.2 MICRON FILTER. DATES OF USE: (B)(6)2010-(B)(6)2010. DIAGNOSIS OR REASON FOR USE: INTESTINAL MALABSORPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODYGUARD BODYGUARD ADMINISTRATION SET WITH 1.2 MICRON FILTER FPA CME AMERICA, LLC 120-112XXF 13845-10

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability