BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDFUSION 2001H SYRINGE INFUSION PUMP

    MDR report key: 5152177 · Received February 27, 2004

    Report

    Report Number
    1036813-2004-00010
    Event Type
    Injury
    Date Received
    February 27, 2004
    Date of Event
    February 4, 2004
    Report Date
    February 27, 2004
    Manufacturer
    MEDEX
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RECEIVED FOR EVALUATION. THE FACILITY OWNS 2001, 2001H, AND 2010H SERIES PUMPS. THE REPORTER WAS UNCERTAIN WHICH PUMP WAS INVOLVED IN THE INCIDENT. MEDEX WAS UNABLE TO CONFIRM THIS ISSUE WITHOUT BENEFIT OF RETURNED PRODUCT. HOWEVER, THE USER MANUAL WARNS THAT UNCONTROLLED FLUID FLOW IS KNOWN TO RESULT WHEN USED WITH SYSTEMS THAT CREATE A HIGH NEGATIVE PRESSURE ENVIRONMENT. MEDEX IS IN THE PROCESS OF LABELING ALL PUMPS WITH THIS INFORMATION AS WELL. MEDEX HAS NOT RECEIVED CONFIRMATION FROM THE FACILITY THAT THE LABELS HAVE BEEN AFFIXED. THE REPORTER STATED THAT THE LABELS HAVE BEEN RECEIVED IN BIOMED. AN ADDITIONAL REPORT WILL BE SUBMITTED SHOULD INFORMATION BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF MEDEX INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE CIRCUIT GENERATED ENOUGH NEGATIVE FLOW PRESSURE TO PULL THE SYRINGE PLUNGER FROM THE PLUNGER HOLDER CAUSING AN UNCONTROLLED FLUID FLOW AND INADVERTENTLY ADMINISTERING A HEPARIN BOLUS. THE PUMP WAS BEING USED IN CONJUNCTION WITH CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 MEDFUSION 2001H SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN MEDEX 2001H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention