BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES

    MDR report key: 9109921 · Received September 24, 2019

    Report

    Report Number
    2026095-2019-00155
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Report Date
    September 24, 2019
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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 23 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: 240 ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2019-00154 FOR THE FIRST REPORT. REFER TO 2026095-2019-00156 FOR THE THIRD REPORT. IT WAS REPORTED THAT A PATIENT HAD A PREVIOUS PUMP THAT EMPTIED PRIOR TO THE INFUSION STOP TIME. "NO INJURY. STATES PATIENT HAS BEEN INSTRUCTED TO MAKE SURE SENSOR IS KEPT CLEAR OF BODY HEAT, AND PUMP IS KEPT FROM BEING UNDER THE COVERS." ADDITIONAL INFORMATION RECEIVED ON 23-SEP-2019 FROM THE USER FACILITY STATED "UPON FURTHER INVESTIGATION ON OUR PART, WE FOUND THOSE PUMPS WERE MIXED INCORRECTLY. THE TOTAL VOLUME WAS NOT CORRECTLY CALCULATED BASED ON THE NUMBER OF HOURS TO BE INFUSED, THUS THE PUMPS INFUSED TOO RAPIDLY. RE-EDUCATION OF THE PHARM TECHS WAS IMPLEMENTED, SO THIS WOULD NOT HAPPEN AGAIN. SO YOUR PRODUCT WAS NOT IN ANY WAY AT FAULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905415 HOMEPUMP C-SERIES ELASTOMERIC LFR MEB AVANOS MEDICAL - IRVINE C270050 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1