BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ELASTOMERIC PUMP

    MDR report key: 16828091 · Received April 27, 2023

    Report

    Report Number
    2026095-2023-00056
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    April 2, 2023
    Report Date
    June 26, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 26-JUN-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.

    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 26-APR-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.

    Description of Event or Problem · 0

    PROCEDURE: TOTAL SHOULDER. DATE OF PROCEDURE: (B)(6) 2023.

    Description of Event or Problem · 0

    FILL VOLUME: UNKNOWN ML . FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT "HAS BEEN EXPERIENCING RINGING IN THE EARS." THE CALLER REPORTED SYMPTOMS HAVE LASTED FOR ABOUT 24-36 HOURS. THE CALLER WAS ADVISED TO IMMEDIATELY CLAMP OFF THE PUMP TUBING AND CALL FOR MEDICAL ATTENTION. FOLLOW-UP WITH THE CALLER NOTED THE SYMPTOMS IMPROVED BUT WERE NOT RESOLVED. THE CALLER WAS REMINDED TO CONTACT THE HEALTHCARE PROFESSIONAL AS SOON AS POSSIBLE. THE "PATIENT PULLED CATHETER OUT EARLY." ADDITIONAL FOLLOW-UP WITH THE CALLER NOTED "PATIENT IS DOING VERY WELL, NO SYMPTOMS OF TINNITUS OR ANY OTHERS. STATES PUMP DID NOT INFUSE TOO FAST, DAD HAD A REACTION ONLY. TAKING IBUPROFEN AND TYLENOL FOR PAIN.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163957 UNKNOWN ELASTOMERIC PUMP ELASTOMERIC HFR MEB AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other