BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIMBUS II FLEX

    MDR report key: 11644057 · Received April 9, 2021

    Report

    Report Number
    3011581906-2021-00013
    Event Type
    Death
    Date Received
    April 9, 2021
    Report Date
    June 2, 2021
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020093
    PMA / PMN Number
    K153193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE PROVIDER OF INFUTRONIX PROVIDED THE EVALUATION REPORT FOR THE AFFECTED PUMP ON 05/07/2021. THE INVESTIGATION RESULTS SHOWED THE AFFECTED DEVICE PASSED ALL THE TESTS, NO ISSUE WAS FOUND ON THE DOWN STREAM OCCLUSION ALARM, AND NO ISSUE WAS FOUND ON THE LOOSE OR DAMAGED CONNECTIONS OR COMPONENTS INSIDE THE PUMP. THE COMPLAINT COULDN'T BE CONFIRMED.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2021-00013.

    Additional Manufacturer Narrative · 1

    INFUTRONIX IS WAITING FOR THE DEVICE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON 3/18/2021, DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER, "I'D LIKE TO SEND A PUMP BACK TO YOU FOR EVALUATION. NO APPARENT PROBLEM WITH THE PUMP, BUT WE HAD A PATIENT THAT HAD A POSSIBLE REACTION TO HIS TREATMENT HOURS AFTER BEING HOOKED UP WITH HOMEGOING 5FU. HE ENDED UP IN THE HOSPITAL SEVERAL HOURS LATER. PUMP WAS STOPPED AND HE WAS DISCONNECTED. THE PATIENT PASSED AWAY SOMETIME IN THE NEXT COUPLE OF WEEKS, I BELIEVE. WE WOULD JUST LIKE TO HAVE THE PUMP TESTED TO RULE OUT ANY INVOLVEMENT OF THE PUMP IN THAT PART OF HIS TREATMENT FOR OUR RECORDS." THE DISTRIBUTOR ALSO STATED THAT PATIENT HARM DOES NOT SEEM TO BE FROM THE PUMP AND THE END USER SEEMS TO AGREE. NO INFORMATION WAS PROVIDED FOR THE EVENT DATE. OPERATOR PATIENT. MEDICATION 5FU. PATIENT INVOLVED. PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540240 NIMBUS II FLEX AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS G 190813360 00817170020093

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H 5FU DATES UNKNOWN.| 5FU DATES UNKNOWN