BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC INTL PAIN RELIEF SYSTEM WITH ONDEMAND, 400 ML X 5 ML/HR + 5 ML PCA

    MDR report key: 8211846 · Received January 3, 2019

    Report

    Report Number
    2026095-2018-00177
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 6, 2018
    Report Date
    February 7, 2019
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651134807
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0202897561, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. 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 ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 02-JAN-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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF THREE EVENTS. REFER TO 2026095-2018-00176 FOR THE FIRST EVENT. REFER TO 2026095-2018-00178 FOR THE THIRD EVENT. FILL VOLUME: 400 ML. FLOW RATE: 5 ML/HR. PROCEDURE: SHOULDER SURGERY. CATHPLACE: POSITIONED ON TOP OF INTERSCALENE (BRACHIAL PLEXUS) NERVE. IT WAS INITIALLY REPORTED THAT A CUSTOMER EXPERIENCED AN BUTTON ISSUE ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. THE PATIENT HAD SHOULDER SURGERY AND IT WAS NOTED THAT THE BOLUS BUTTONS OF THREE ON DEMAND PUMPS DID NOT POP BACK UP AFTER USAGE. THE BOLUS RESERVOIR DID NOT FILL AND NO LONGER WORKED. ADDITIONAL INFORMATION RECEIVED ON 11-DEC-2018 STATED THAT THE PRIMING TAB WAS REMOVED PRIOR TO PATIENT USE AND FILLED BY THE PHARMACY HOSPITAL. IT WAS NOTED THAT THE BOLUS BUTTON WAS DEPRESSED FIRST IN THE HOSPITAL AND THEN LATER AT HOME WITH THE PATIENT. NO SPECIFIC INFORMATION ON HOW MANY TIMES IT WAS DEPRESSED AT HOME. THE PATIENT STRUGGLED A LOT WITH THE USE OF THE BOLUS BUTTON. IT WAS NOTED THAT THE BOLUS BUTTON WAS STUCK AND DID NOT POP BACK UP WITHIN 30 MINUTES WITH THE ORANGE MARKET AT THE BOTTOM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4640 ON-Q C-BLOC INTL PAIN RELIEF SYSTEM WITH ONDEMAND, 400 ML X 5 ML/HR + 5 ML PCA ELASTOMERIC - ONDEMAND MEB AVANOS MEDICAL - IRVINE CBI003 0202897561 30680651134807

    Patients

    Seq Age Sex Outcome Treatment
    1 PLEXUS CATHETER| ROPIVACAINE 0.2%