BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3854012 · Received May 21, 2014

    Report

    Report Number
    2016493-2014-00252
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    March 29, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO HOSP NAME, ADDRESS, OR CONTACT PERSON IS LISTED; NO PHONE OR EMAIL IS PROVIDED. ALL OF THE ALLOWABLE INFO HAS BEEN PROVIDED AND NO FURTHER INFO IS OR WILL BE MADE AVAILABLE.

    Description of Event or Problem · 1

    RECEIVED FROM THE FDA A COPY OF MAUDE EVENT REPORT WHICH STATES: "PUMP MODULE FAILED WHILE INFUSING FLUIDS. NO PT INJURY. REASON FOR USE: ANEMIA." CONFLICTING INFO IN THE REPORT: EVENT TYP, IS LISTED AS INJURY, AND EVENT OUTCOME IS LISTED AS REQUIRED INTERVENTION, HOWEVER, TEXT STATES "NO PT INJURY". NO OTHER DETAILS WERE PROVIDED AND NO CUSTOMER ENTITY OR CONTACT PERSON IS LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303428 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE ADMINISTRATION SET,| MODEL/LOT #UNK