BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMEPUMP C-SERIES 125ML 5ML/HR

    MDR report key: 9132164 · Received September 27, 2019

    Report

    Report Number
    2026095-2019-00157
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 27, 2020
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    UDI-DI
    10680651135633
    PMA / PMN Number
    1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0202861596, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. 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 · 0

    THE SAMPLE DEVICE WAS EVALUATED. FLOW RATE TESTING WAS PERFORMED AND THE DEVICE MET SPECIFICATIONS. A ROOT CAUSE WAS NOT IDENTIFIED. ALL INFORMATION REASONABLY KNOWN AS OF 26-FEB-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 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

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: 300PU INFUSION OF ROPIVACAINE + 200 MCG OF FENTANYL. THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 27-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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FILL VOLUME: 125 ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. DAY / TIME FILLED PUMP: (B)(6) 2019. DAY / TIME START INFUSION: (B)(6) 2019. DAY / TIME END INFUSION: (B)(6) 2019. MEDICATION: 300PU INFUSION OF ROPIVACAINE AND 200 MCG OF FENTANYL/ DILUTED IN 80 ML OF PHYSIOLOGICAL SOLUTION, NORMAL SALINE. IT WAS REPORTED AFTER THE SURGERY, THE POSTOPERATIVE ANALGESIA PUMP INFUSED CONTINUOUSLY. THE DEVICE INFUSED IN 6-HOURS INSTEAD OF 24-HOURS. THE PATIENT EXPERIENCED DIZZINESS, NAUSEA, HYPOTENSION WITH A BLOOD PRESSURE 80/50 MMHG, TACHYCARDIA, SENSORY AND MOTOR BLOCK ON LEGS. MEDICAL INTERVENTION INVOLVED REMOVING THE EQUIPMENT AND ADMINISTERING 1000CC LOAD OF HARTMAN SOLUTION PLUS 10 MG OF EPHEDRINE INTRAVENOUS (IV). THE PUMP WAS ABOVE THE PUMP. THE PATIENT WAS EVENTUALLY DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922223 HOMEPUMP C-SERIES 125ML 5ML/HR ELASTOMERIC LFR MEB HALYARD - IRVINE C125050 0202861596 10680651135633

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention