BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 2212932 · Received August 3, 2011

    Report

    Report Number
    9616066-2011-00443
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 08/03/2011. INTERNAL FILE NO: (B)(4). PT'S INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED. THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CLINICIAN REPORTED BLOOD BACKED UP PAST THE FILTER INTO THE IV LINE. THE MALE LUER WAS NOTED TO BE CRACKED. THE PT WAS ON ECMO WITH THREE INFUSIONS RUNNING. DOPAMINE, EPINEPHRINE, AND D5 0.45 NORMAL SALINE WERE INFUSING. THE PT'S BLOOD PRESSURE DROPPED AND WHEN THE NURSE INVESTIGATED THE THREE IV LINES, SHE FOUND BLOOD BACKED UP ON THE ONE LINE PAST THE TRI-PORT EXTENSION INTO THE FILTER, THEN INTO THE PRIMARY IV LINE. SHE FLUSHED THE LINE. THE PT CODED AND RECOVERED SUCCESSFULLY AND IS STILL ON ECMO. CUSTOMER STATES THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE EXTENSION SET FPA CAREFUSION CORP. 20028E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Life Threatening| R