BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    MDR report key: 1224599 · Received November 3, 2008

    Report

    Report Number
    6000001-2008-00697
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 16, 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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF THE SAMPLE, AND COMPLETION OF THE COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    THE NATIONAL COMPLIANT COORDINATOR (NNC) FOR INTN'L AFFILIATE RECEIVED A COMPLAINT FROM A USER FACILITY INVOLVING A PATIENT CONTROL MODULE (PCM) ATTACHED TO A BASAL/BOLUS INFUSOR LV. ACCORDING TO THE FACILITY, THE DEVICE OVER-INFUSED DURING PATIENT USE. THE DEVICE INFUSED MEDICATION AT A REPORTED RATE OF 7.5 ML/HOUR. THE DEVICE WAS FILLED WITH MORPHINE HYDROCHLORIDE, 2% ROPIVACAINE HYDROCHLORIDE HYDRATE 200ML AND CONNECTED TO PATIENT VIA CATHETER. 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. 08E069

    Patients

    Seq Age Sex Outcome Treatment
    1