BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3760067 · Received December 17, 2013

    Report

    Report Number
    1314492-2013-22036
    Event Type
    Injury
    Date Received
    December 17, 2013
    Date of Event
    August 30, 2013
    Report Date
    November 19, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION IS IN PROGRESS. WHEN THE EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT A DEVICE MALFUNCTION OCCURRED AND THIS EVENT IS BEING SUBMITTED DUE TO THE PATIENT INJURY RESULTING FROM THE REPORTED INFILTRATION. AN INFILTRATION CAN CAUSE SERIOUS MEDICAL PROBLEMS, THAT WOULD REQUIRE MEDICAL AND POSSIBLY SURGICAL INTERVENTION TO PREVENT PERMANENT DAMAGE. IF NOT TREATED IN A TIMELY MANNER, IT CAN LEAD TO EXTRAVASATION, AND SURGICAL INTERVENTION. THE SPECIFIC MEDICAL INTERVENTION REQUIRED IS UNKNOWN. WITH THE INFORMATION PROVIDED, THIS INCIDENT WOULD BE CONSIDERED A SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFILTRATION OCCURRED DURING AN INFUSION ON A PATIENT IN THE PEDIATRIC CARE AREA AND THE PUMP DID NOT ALARM FOR A DOWNSTREAM OCCLUSION. IT WAS ALSO REPORTED THERE WAS AN INJURY AND MEDICAL INTERVENTION. THE EXTENT OF THE INJURY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658241 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention