BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANOS HOMEPUMP ECLIPSE AMBULATORY INFUSION SYSTEMS

    MDR report key: 12162456 · Received July 13, 2021

    Report

    Report Number
    2026095-2021-00076
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    May 23, 2021
    Report Date
    July 13, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    UDI-DI
    00193494135515
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 12 JUL 2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FILL VOLUME: 103ML. FLOW RATE: 200ML/HR. PROCEDURE: UNKNOWN. CATHETER PLACEMENT: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED VIA MW5101625 THAT "PATIENT HAD RASH, NAUSEA, AND FACIAL DYSESTHESIA." PER ADDITIONAL INFORMATION RECEIVED 9 JUL 2021, "PATIENT IS A (B)(6) YEAR OLD (B)(6) KG MALE TREATED WITH CEFTRIAXONE. PATIENT IS STABLE. THE ECLIPSE SIZE USED WAS 200 ML/HR 100 ML. DEVICE WAS FILLED WITH 83 ML OF SODIUM CHLORIDE 0.9% SOLUTION, PRIMED, THEN 20 ML OF CEFTRIAXONE WAS ADDED TO THE DEVICE. THE DEVICE WAS DISCARDED BY THE PATIENT CAREGIVER." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057063 AVANOS HOMEPUMP ECLIPSE AMBULATORY INFUSION SYSTEMS ELASTOMERIC HFR MEB AVANOS MEDICAL INC. E102000 UNKNOWN 00193494135515

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other