BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV 5 ML/H SYSTEM

    MDR report key: 1230553 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-98818
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 14, 2007
    Report Date
    June 18, 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

    A REVIEW OF ALL RECORDS RELATED TO THE MANUFACTURE OF LOT 07B055 HAS BEEN REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT. 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 FOR INT'L AFFILIATE REPORTED AN ALLEGED OVERINFUSION OBSERVED ON AN INFUSOR DEVICE DURING PATIENT INFUSION VIA INTRAVENOUS INJECTION. THE DEVICE WAS FILLED WITH 70ML OF 5-FU AND 160ML OF SALINE. THE TOTAL FILL VOLUME WAS 230ML. THE PATIENT ACCESS SITE WAS A NEEDLE CONNECTION. THE LOCATION OF THE ACCESS SITE WAS UNKNOWN. THE EXPECTED DURATION OF INFUSION WAS 46 HOURS. THE CUSTOMER INDICATED THAT 230ML OF THE DRUG INFUSED IN 36 HOURS. THE INFUSOR WAS AT THE SAME HEIGHT AS THE FLOW RESTRICTOR. THE TEMPERATURE OF THE DEVICE WAS 31 DEGREES CELCIUS. THE DEVICE WAS NOT USED PRIOR TO THE INCIDENT. A PATIENT CONTROL MODULE WAS NOT USED. 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 INFUSOR LV 5 ML/H SYSTEM 80MEB MEB BAXTER HEALTHCARE CORPORATION 07B055

    Patients

    Seq Age Sex Outcome Treatment
    1