BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES

    MDR report key: 9101904 · Received September 22, 2019

    Report

    Report Number
    2026095-2019-00153
    Event Type
    Malfunction
    Date Received
    September 22, 2019
    Report Date
    September 22, 2019
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 19 SEP 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT "A PATIENT COME TO GET FOLFOX [CHEMOTHERAPY] TREATMENT ON (B)(6) 2019; HE CALLED IN ON (B)(6) 2019 TO REPORT THAT HIS PUMP FINISHED IN 1 DAY INSTEAD OF THE 2. HIS SUBSEQUENT TREATMENT ENDED UP BEING DELAYED BY 2 WEEKS BECAUSE HE DID HAVE SOME SIDE EFFECTS, LIKELY FROM THE RAPID INFUSION (HE SAID THAT AT THE END OF THE WEEK, HE WENT TO BED ON SATURDAY PM, AND THEN WOKE UP SUNDAY AM HURTING ALL OVER; HE THEN REPORTED SLEEPING FOR [ABOUT] 36 HOURS; JOINTS/MUSCLES WERE ACHING ALL OVER FOR SEVERAL DAYS; NEUROLOGICALLY FELT FOGGYNOT RIGHT; DID NOT START FEELING BETTER UNTIL THE END OF THE SECOND WEEK AFTER HIS CHEMOTHERAPY BUT EVEN WHEN I SAW HIM AFTER THE 2 WEEK DELAY, HE WASN¿T AS ENERGETIC AS USUAL)." THE PATIENT "DENIED ANY MANIPULATION TO THE PUMP OR EXPOSURE TO EXCESSIVE HEAT." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895653 HOMEPUMP C-SERIES ELASTOMERIC LFR MEB AVANOS MEDICAL - IRVINE C270050 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1