BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE 2 ML PATIENT CONTROL MODULE SINGLE PACK 6/CARTON

    MDR report key: 1210027 · Received October 21, 2008

    Report

    Report Number
    6000001-2008-00650
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 6, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURING FACILITY, THEREFORE, THE INVESTIGATION HAS NOT YET BEEN INITIATED. 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 INVOLVING THE PATIENT CONTROL MODULE (PCM). ACCORDING TO THE FACILITY, THE DEVICE OVER-INFUSED DURING PATIENT USE. THE DEVICE WAS USED IN CONJUNCTION WITH A BASAL/BOLUS INFUSOR WHICH WAS FILLED WITH ROPIVACAINE HYDROCHLORIDE HYDRATE 27ML, FENTANYL CITRATE 25ML, SALINE 40ML AND CONNECTED TO A PATIENT VIA CATHETER. THE FACILITY REPORTED THAT DEVICE DELIVERED MEDICATION AT A FLOW RATE OF 30ML/8HOURS. 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 MODULE SINGLE PACK 6/CARTON 80MEA MEA BAXTER HEALTHCARE CORP. 08E011

    Patients

    Seq Age Sex Outcome Treatment
    1