BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED TRITON FP POLE MOUNT INFUSION PUMP

    MDR report key: 5953504 · Received September 15, 2016

    Report

    Report Number
    1723533-2016-00171
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 24, 2016
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FRN
    PMA / PMN Number
    K070529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO WALKMED INFUSION FOR EVALUATION AND WAS OBSERVED TO MEET SPECIFICATION. WALKMED INFUSION WAS UNABLE TO CONFIRM A MALFUNCTION WITH THE DEVICE'S AIR DETECTION SYSTEM. A REVIEW OF THE MANUFACTURING AND SERVICE RECORDS DID NOT REVEAL ANY NONCONFORMITIES RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING TREATMENT, THE CLINICIAN OBSERVED THE DEVICE IN QUESTION (SERIAL NUMBER (B)(4)) WAS PRODUCING AN "AIR IN LINE" ALARM. THE CLINICIAN ALSO OBSERVED THE MEDICATION BAG WAS EMPTY AND SOME OF THE PATIENT'S BLOOD HAD BACKED UP INTO THE LINE. WALKMED INFUSION WAS UNABLE TO CONFIRM IF THE DEVICE IN QUESTION INFUSED AIR INTO THE PATIENT. THE PATIENT EXPERIENCED CHEST PAIN AND HAD DIFFICULTY BREATHING. THE PATIENT'S VITALS WERE REPORTED TO BE STABLE, AND THE CLINICIAN INSTRUCTED THE PATIENT TO LAY ON THEIR LEFT SIDE. THE PATIENT'S CHEST DISCOMFORT SUBSIDED AFTER AN HOUR, AND THE PATIENT WAS SENT HOME. THE INFUSED MEDICATION WAS OCTAGAM 5%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605248 WALKMED TRITON FP POLE MOUNT INFUSION PUMP INFUSION PUMP FRN WALKMED INFUSION, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R