BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT CONTROL MODULE WATCH, 12 PACK

    MDR report key: 1193172 · Received October 7, 2008

    Report

    Report Number
    6000001-2008-00600
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    June 24, 2008
    Report Date
    September 12, 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 WAS RECEIVED HOWEVER SAMPLE EVALUATION 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 BAXTER JAPAN RECEIVED A COMPLAINT FROM A USER FACILITY INVOLVING THE BASAL/BOLUS INFUSOR WITH A PCA WATCH ATTACHED. THE DEVICE WAS FILLED WITH MEDICATION (FENTANYL CITRATE 20ML) AND CONNECTED TO A PATIENT. ACCORDING TO THE FACILITY, THE DEVICE OVER-INFUSED DURING PATIENT USE. 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 PATIENT CONTROL MODULE WATCH, 12 PACK 80MEA MEA BAXTER HEALTHCARE CORP. 07M014

    Patients

    Seq Age Sex Outcome Treatment
    1