BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    MDR report key: 1244799 · Received November 13, 2008

    Report

    Report Number
    6000001-2008-00742
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 14, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEA
    PMA / PMN Number
    K051253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURING FACILITY, THEREFORE, THE INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED, UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE NATIONAL COMPLAINT COORDINATOR (NCC) FOR INTN'L AFFILIATE RECEIVED A COMPLAINT FROM A USER FACILITY INVOLVING THE PATIENT CONTROL MODULE (PCM). ACCORDING TO THE FACILITY, WHILE CONNECTED TO THE BASAL/BOLUS INFUSOR, THE SYSTEM OVER-INFUSED DURING PATIENT USE. THE DEVICE WAS FILLED WITH 100ML OF MEDICATION (0.2% ROPIVACAINE HYDROCHLORIDE HYDRATE 88ML, FENTANYL CITRATE 12ML) AND COMPLETED INFUSION IN 24 HOURS. THE FACILITY ALSO REPORTED THAT THE FLOW RESTRICTOR WAS KEPT AT THE SAME LOCATION AS THE DEVICE AND THE DEVICE WAS KEPT AT A TEMPERATURE OF 30C. THERE WAS NO ADVERSE PATIENT OUTCOME, INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THE ALLEGED INCIDENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON 80MEA MEA BAXTER HEALTHCARE CORP. 08C048

    Patients

    Seq Age Sex Outcome Treatment
    1