BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASAL/BOLUS INFUSOR, 12 PACK 03.5ML/H X 15 MIN

    MDR report key: 5550432 · Received August 20, 2007

    Report

    Report Number
    6000001-2007-09249
    Event Type
    Malfunction
    Date Received
    August 20, 2007
    Date of Event
    July 24, 2007
    Report Date
    July 24, 2007
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEB
    PMA / PMN Number
    K905778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF ALL RECORDS RELATED TO THE MANUFACTURE OF LOT 06M001 HAS BEEN REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE (B)(6) COMPLAINT COORD FOR BAXTER (B)(4), REPORTED AN ALLEGED OVER-INFUSION OBSERVED ON A BASAL/BOLUS INFUSOR VIA HYPODERMIC INJECTION. THE DEVICE WAS FILLED WITH 6ML. OF OCTREOTIDE ACETATE, AND 18ML OF NORMAL SALINE. THE TOTAL FILL VOLUME WAS 24ML. THE FACILITY REPORTED THAT 24ML OF MEDICATION INFUSED IN 16 HOURS. THE DEVICE WAS NOT USED PRIOR TO THE INCIDENT. IN ADDITION, PATIENT CONTROL MODULE (PCM) WAS NOT USED WITH THE DEVICE. THE TEMPERATURE OF THE DEVICE WAS APPROXIMATELY 30 DEGREES CELSIUS. THE FOLLOWING INFORMATION WAS NOT KNOWN: EXPECTED DURATION OF INFUSION AND THE LOCATION OF THE INFUSOR DEVICE RELATIVE TO THE FLOW RESTRICTOR. 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 BASAL/BOLUS INFUSOR, 12 PACK 03.5ML/H X 15 MIN 80MEB MEB BAXTER HEALTHCARE CORP. 06M001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK