BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE PUMP ADMINISTRATION SET

    MDR report key: 3820795 · Received April 30, 2014

    Report

    Report Number
    9616066-2014-00386
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 15, 2014
    Report Date
    April 3, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2014. INTERNAL FILE NO: (B)(4). THIS REPORT WAS FILED BY THE MFR. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT. THE CUSTOMER STATED THE SET HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    THE SET WAS NOT IN THE PUMP AT THE TIME OF THE EVENT; THE NURSE SELECTED A PORT CLOSEST TO PT TO ADMINISTER EPINEPHRINE TV PUSH. SHE OCCLUDED THE TUBING ABOVE THE INJECTION PORT AND ADMINISTERED THE MEDICATION. FOLLOWING ADMINISTRATION SHE RELEASED THE OCCLUSION. THE "RUBBERY CHAMBER" LOCATED IN THE ACCUSLIDE FLOW REGULATOR RUPTURED AND SPRAYED FLUID. THERE WAS NO PT OR STAFF HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL EVENT OR PT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259558 ALARIS SE PUMP ADMINISTRATION SET FPA CAREFUSION CORP 72033E 13125977

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK