BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN C-SERIES PUMP

    MDR report key: 16639513 · Received March 29, 2023

    Report

    Report Number
    2026095-2023-00036
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Report Date
    March 29, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 29-MAR-2023 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. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. 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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED NINE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING NINE DIFFERENT EVENTS. THIS IS THE THIRD OF NINE REPORTS. REFER TO 2026095-2023-00034 FOR THE FIRST INCIDENT. REFER TO 2026095-2023-00035 FOR THE SECOND INCIDENT. REFER TO 2026095-2023-00037 FOR THE FOURTH INCIDENT. REFER TO 2026095-2023-00038 FOR THE FIFTH INCIDENT. REFER TO 2026095-2023-00039 FOR THE SIXTH INCIDENT. REFER TO 2026095-2023-00040 FOR THE SEVENTH INCIDENT. REFER TO 2026095-2023-00041 FOR THE EIGHTH INCIDENT. REFER TO 2026095-2023-00042 FOR THE NINTH INCIDENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN . PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNKNOWN. IT WAS REPORTED THE ECLIPSE PUMP WAS INFUSING "MUCH SOONER THAN EXPECTED." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060578 UNKNOWN C-SERIES PUMP ELASTOMERIC LFR MEB AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown