BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSYSTEM III PUMP MODULE ADMINISTRATION SET

    MDR report key: 2926245 · Received January 16, 2013

    Report

    Report Number
    9616066-2013-00022
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K874564
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SET HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNREGULATED FLOW OF PROPOFOL; DETAILS OF THE EVENT WERE PROVIDED AS FOLLOWS: AN INFUSION OF PROPOFOL WAS STARTED AT 70 MCG (22 ML/HR) AND 10 MINUTES LATER, THE PUMP MODULE ALARMED FOR PT-SIDE OCCLUSION. THE ALARM WAS ACKNOWLEDGED, THE INFUSION WAS RESTATED AND THE USER NOTICED THE FLUID WAS DRIPPING SIGNIFICANTLY FASTER THAN EXPECTED. THE USER PRESSED STOP ON THE PUMP BUT FLUID CONTINUED TO DROP QUICKLY INTO THE CHAMBER AND CONTINUED TO INFUSE. THE SET WAS CLAMPED AND DISCONNECTED FORM THE PT. THE ISSUE WAS REPLICATED WHILE NOT CONNECTED TO THE PT. THE IV SET WAS REPLACED, THE INFUSION WAS RESTARTED AND RAN AS EXPECTED WITHOUT ANY OCCURRENCE OF RAPID OR UNREGULATED FLOW. THE CUSTOMER STATED THAT "APPROXIMATELY 25-30 ML OF PROPOFOL HAD INFUSED IN THIS PT IN A MATTER OF MINUTES. THE PT'S VITALS HAD BEEN TAKEN REGULARLY DURING THIS OCCURRENCE AND BESIDES A MAP DROP FROM 95 TO 70 AND A HR DROP FROM 118 10 100 THE PT SEEMED COMPLETELY STABLE." ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23846 MEDSYSTEM III PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 28293E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MEDSYSTEM III INFUSION PUMP, SN UNK