BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3021089 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00175
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 21, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURETTE SET FELL APART DURING A TPN INFUSION ON AN INFANT. THE INFANT'S BLOOD SUGAR DROPPED TO 63. A NEW BAG OF FLUIDS WAS HUNG. THERE WAS NO REPORT OF MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106429 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2141-0600 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other ALARIS PUMP MODULE: SN UNKNOWN| ALARIS PC UNIT: SN UNKNOWN