BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP)

    MDR report key: 9927133 · Received April 5, 2020

    Report

    Report Number
    2026095-2020-00053
    Event Type
    Malfunction
    Date Received
    April 5, 2020
    Report Date
    April 5, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    10680651135664
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 03-APR-2020 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 2026095-2020-00050 FOR THE FIRST EVENT. REFER TO 2026095-2020-00051 FOR THE SECOND EVENT. REFER TO 2026095-2020-00052 FOR THE THIRD EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: 2 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED, THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390036 HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP) ELASTOMERIC LFR MEB AVANOS MEDICAL - IRVINE C270020 UNKNOWN 10680651135664

    Patients

    Seq Age Sex Outcome Treatment
    1