BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODEL ADMINISTRATION SET

    MDR report key: 2725232 · Received August 22, 2012

    Report

    Report Number
    9616066-2012-00592
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 2, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, BUT IT HAS NOT BEEN EVALUATED YET. A F/U REPORT WILL BE SUBMITTED WITH THE FAILURE INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    MANAGER OF PRE-OP AND PACU REPORTED A PT WAS TRANSFERRED INTO PACU FROM OPERATING ROOM WITH A GRAVITY INFUSION OF LACTATED RINGERS. WHEN THE NURSE WAS CHECKING THE PT IN AND DOING HER ASSESSMENT, SHE FOUND THE PORT NEAREST TO THE IV SITE WITH FLUID FREELY POURING FROM IT. THE TUBING WAS CHANGED AND THERE WAS NO HARM TO THE PT. THE INFUSION WAS LIKELY STARTED IN POH (PRE-OP HOLDING) AND WAS IN USE FOR ABOUT 2 HOURS PRIOR TO LEAK BEING NOTED. NO REPORT OF LEAKING DURING PRIMING. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODEL ADMINISTRATION SET FPA CAREFUSION CORP 11419365 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR