BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 1654044 · Received April 5, 2010

    Report

    Report Number
    1722139-2010-00043
    Event Type
    Death
    Date Received
    April 5, 2010
    Date of Event
    March 29, 2010
    Report Date
    March 31, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MMDG IS WORKING WITH THE (B) (6) SHERIFF'S DEPT., SGT (B) (6), TO COORDINATE RETURN AND EVALUATION OF THE PUMP IN QUESTION. THIS INITIAL REPORT IS BEING SENT TO COMPLY WITH A 5 DAY REPORTING REQUIREMENT FOR COMPLAINTS ASSOCIATED WITH PT'S DEATH. WE ARE CONTINUING TO PURSUE EVALUATION OF THIS DEVICE. AS FURTHER INFO AND / OR PUMP EVAL BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: MMDG REC'D AN EMAIL ON (B) (6) 2010 FROM SGT (B) (6) WITH (B) (6). THE SHERIFF REPORTED THAT A (B) (6) BOY HAD DIED WHILE IN FOSTER CARE. THE SGT ALSO INDICATED, THE CHILD HAD VARIOUS HEALTH ISSUES. THERE WAS NO KNOWN PUMP FAILURE BUT AS PART OF THE ONGOING INVESTIGATION, HE WOULD REQUIRE THE PUMP HISTORY. PT INJURY: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO