BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE 2 ML PATIENT CONTROL MODULE SINGLE PACK 6/CARTON

    MDR report key: 1297700 · Received November 24, 2008

    Report

    Report Number
    6000001-2008-00781
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 5, 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 RETURNED FOR AN EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF THE SAMPLE, AND COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE NATIONAL COMPLAINT COORDINATOR (NCC) FOR BAXTER JAPAN, RECEIVED A COMPLAINT FROM A USER FACILITY INVOLVING THE BASAL/BOLUS INFUSOR LV WITH AN ATTACHED PATIENT CONTROL MODULE (PCM). ACCORDING TO THE FACILITY, THE DEVICE OVER-INFUSED DURING PATIENT USE. THE DEVICE WAS FILLED WITH 80 ML OF MEDICATION (FENTANYL CITRATE 12 ML, "DILUTE SOLUTION" 68 ML), AND CONNECTED TO THE PATIENT VIA EPIDURAL TUBING. THE FACILITY REPORTED THAT INFUSION COMPLETED IN 10 HOURS AND THAT THE FLOW RESTRICTOR WAS KEPT AT THE SAME HEIGHT AS THE DEVICE. 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. 08F045

    Patients

    Seq Age Sex Outcome Treatment
    1