BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR

    MDR report key: 9595636 · Received January 16, 2020

    Report

    Report Number
    2026095-2020-00009
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    November 27, 2019
    Report Date
    February 11, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    10680651134728
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 11-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 · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 31-JAN-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.

    Description of Event or Problem · 0

    THIS REPORT HAS BEEN CONFIRMED A DUPLICATE OF REPORT NUMBER 2026095-2020-00008. NO ADDITIONAL INFORMATION WILL BE SUBMITTED FOR REPORT NUMBER. ANY FURTHER INFORMATION CONCERNING THIS EVENT WILL BE SUBMITTED UNDER REPORT NUMBER 2026095-2020-00008.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 15-JAN-2020 STATED: FILL VOLUME: 550ML. DATE AND TIME INFUSION STARTED: (B)(6) 2019, 16:00. DATE AND TIME INFUSION ENDED: (B)(6) 2019, 8:00.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 14-JAN-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. 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). MW5091377.

    Description of Event or Problem · 1

    FILL VOLUME: UNKNOWN. FLOW RATE: 10 ML/HR. PROCEDURE: TOTAL KNEE ARTHROPLASTY. CATHPLACE: ADDUCTOR CANAL CATHETER. IT WAS REPORTED THE PUMP DELIVERED A LARGE OVERDOSE OF ROPIVACAINE CREATING LEG NUMBNESS THAT RESOLVED 1-HOUR TO 2-HOURS AFTER INFUSION WAS STOPPED. ADDITIONAL INFORMATION WAS RECEIVED ON 27-DEC-2019 VIA MEDWATCH/ FDA USER FACILITY REPORT NUMBER, MW 5091377 EVENT DESCRIPTION: PT [PATIENT] EXPERIENCED ALMOST TOTAL LOSS OF SENSATION AND MOTOR FUNCTION IN LEG BELOW THE KNEE WHILE A PAIN PUMP WAS RUNNING. THE PUMP WAS ATTACHED TO AN ADDUCTOR CANAL CATHETER, WHICH HAD BEEN FUNCTIONING NORMALLY THE NIGHT BEFORE WITH ONLY MILD NUMBNESS AT THAT TIME. WHEN SHE WOKE UP ON POSTOPERATIVE DAY1 AFTER TOTAL KNEE ARTHROPLASTY, HER LEG WAS VERY NUMB, SHE HAD MINIMAL MOTOR FUNCTION, AND LOSS OF PROPRIOCEPTION IN THAT LEG. PUMP WAS SET AT 10 ML/HOUR AND NOT CHANGED THROUGHOUT THE PROCESS. NO LEAKAGE NOTED. DIAGNOSIS FOR USE POSTOPERATIVE PAIN IN KNEE.-CR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61701 ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR ELASTOMERIC - SAF MEB AVANOS MEDICAL - IRVINE CB004 0203122169 10680651134728

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention ROPIVICAINE 0.2%