BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3202285 · Received June 24, 2013

    Report

    Report Number
    2016493-2013-00281
    Event Type
    Death
    Date Received
    June 24, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE BIOMED REQUESTED A PUMP AND EVENT LOG EVAL FOR A SET OF DEVICES WHICH WERE USED WITH A VERY SICK PT IN THE SPECIAL CARE NURSERY. HE STATED, "EVERYTHING APPEARED TO WORK AS IT SHOULD." TWO SETS OF DEVICES WERE UTILIZED. THE FIRST SET OF PUMPS INCLUDED A PUMP MODULE ((B)(4)) AND A PC UNIT ((B)(4)). THE SECOND SET INCLUDED TWO PUMP MODULES ((B)(4)) AND A PC UNIT ((B)(4)). THE CUSTOMER STATED THE USER DID NOT PROVIDE ANY ADDITIONAL PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285830 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE ADMIN SETS: MODEL/LOT #'S UNK| ALARIS PC UNIT: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)