BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2943994 · Received January 30, 2013

    Report

    Report Number
    9616066-2013-00062
    Event Type
    Death
    Date Received
    January 30, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 3, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECT PRODUCT HAS BEEN REC'D AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY WERE "RESUSCITATING A PT IN THE ICU WHO WAS NEARLY CODING AND THE NURSE WAS ORDERED TO GIVE A BOLUS OF FLUIDS TO THE PT. THE RN SET THE IV PUMP USING THE TUBING AT A RATE OF 999 AND SUDDENLY THE TUBING BURST INSIDE THE PUMP." THE CUSTOMER STATED THAT NO PRESSURE BAG WAS USED AND SHE DOES NOT KNOW HOW LONG THE SET HAD BEEN IN USE. PER CUSTOMER PHOTOS, THE SILICONE SEGMENT HAD FULLY SEPARATED FROM THE UPPER FITMENT WITH THE O RING VISIBLE IN THE PHOTO BUT NOT ATTACHED TO EITHER THE SILICONE OR THE UPPER FITMENT. IT WAS FURTHER REPORTED THAT THE PT EXPIRED FROM HIS/HER UNDERLYING CONDITION. THE RPTR DID NOT FEEL THE DEATH WAS RELATED IN ANY WAY TO THE TUBING EVENT. THE RPTR STATED THAT NO FURTHER PT OR EVENT DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41026 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS PC UNIT, SN UNK| PUMP MODULE, SN UNK