BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8854518 · Received August 2, 2019

    Report

    Report Number
    2026095-2019-00142
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    June 19, 2019
    Report Date
    October 18, 2019
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651135682
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: E1. CORRECTION: H4. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2019 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 · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0203007612, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 31-JUL-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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FILL VOLUME: 241 ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE DEVICE COMPLETED THE INFUSION AT 0330. THE DEVICE WAS SUPPOSED TO COMPLETE THE INFUSION AT 1540. THE TOTAL TIME OF THE INFUSION WAS 33-HOURS. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651795 HOMEPUMP C-SERIES*, 270 ML, 5 ML/HR (CONTAINS DEHP) ELASTOMERIC LFR MEB AVANOS MEDICAL - IRVINE C270050 0203007612 30680651135682

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR FLUORURACILA 500 MG| FLUORURACILA 500 MG