BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAPANESE BASAL/BOLUS INFUSOR 2 X 2 X 15 MIN

    MDR report key: 1230125 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-98819
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 18, 2007
    Report Date
    June 19, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K905778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING PLANT RECEIVED THE DEVICE INVOLVED IN THE INCIDENT. HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. UPON COMPLETION, THE EVALUATION RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    NATIONAL COMPLAINT COORDINATOR (NCC) FOR INT'L AFFILIATE REPORTED AN ALLEGED OVERINFUSION OBSERVED ON AN INFUSOR DEVICE DURING PATIENT INFUSION VIA EPIDURAL INJECTION. THE DEVICE WAS FILLED WITH 50ML OF ROPIVACAINE HYDROCHLORIDE, 1ML OF DROPERIDOL, AND 0.6ML OF MORPHINE HYDROCHLORIDE. THE DILUENT USED WAS UNKNOWN. THE TOTAL FILL VOLUME WAS 51.6ML. THE PATIENT ACCESS SITE WAS A NEEDLE CONNECTION. THE LOCATION OF THE ACCESS SITE WAS UNKNOWN. THE CUSTOMER REPORTED THAT 35.6ML OF THE DRUG INFUSED INTO THE PATIENT WITHOUT PROBLEM, LEAVING 16ML OF THE DRUG IN THE DEVICE. HOWEVER, 16ML INFUSED IN 2 HOURS, INSTEAD OF THE EXPECTED 8 HOURS. THE POSITION OF THE INFUSOR WITH RESPECT TO THE FLOW RESTRICTOR WAS NOT KNOWN. IT WAS NOT KNOWN WHETHER OR NOT THE DEVICE WAS EXPOSED TO A HEAT SOURCE. THE DEVICE WAS NOT USED PRIOR TO THE INCIDENT. A 2ML PATIENT CONTROL MODULE, WITH LOT 07B043, WAS ATTACHED BUT WAS NOT PRESSED. THERE WERE NO REPORTS OF PATIENT OUTCOME, INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAPANESE BASAL/BOLUS INFUSOR 2 X 2 X 15 MIN 80MEB MEB BAXTER HEALTHCARE CORPORATION 07A010

    Patients

    Seq Age Sex Outcome Treatment
    1