BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP)

    MDR report key: 9714959 · Received February 14, 2020

    Report

    Report Number
    2026095-2020-00016
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    February 6, 2019
    Report Date
    February 14, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    10680651135688
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 14-FEB-2020 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 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 · 1

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE FOURTH OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: 5ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 13:16. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED 7-HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177607 HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP) ELASTOMERIC LFR MEB AVANOS MEDICAL - IRVINE C270050 UNKNOWN 10680651135688

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR