BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 4173279 · Received September 25, 2014

    Report

    Report Number
    2016493-2014-00449
    Event Type
    Injury
    Date Received
    September 25, 2014
    Report Date
    August 27, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT SEQUESTERED BY THE CUSTOMER. BECAUSE THE CUSTOMER DID NOT RECORD THE DEVICE SERIAL NUMBER AND NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PUMP HAD "FAILED" AND THE PT NEEDED TO BE RESUSCITATED. ALTHOUGH THIS REPORT WAS MADE IN THE CONTEXT OF A DISCUSSION ABOUT CORRODED IUI CONNECTORS, NO INFO IS CURRENTLY AVAILABLE ABOUT THE EVENT. THE CUSTOMER STATES THAT SHE DID NOT KNOW THAT SHE NEEDED TO REPORT THE EVENT AND THAT THE PUMP WAS LIKELY REPAIRED AND PUT BACK INTO SERVICE AND THAT NO LASTING HARM OCCURRED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597218 UNK PUMP, INFUSION FRN CAREFUSION CORP UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention