BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT PAIN CONTROL SYSTEM, PIB/PCA

    MDR report key: 17770140 · Received September 18, 2023

    Report

    Report Number
    2026095-2023-00100
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 24, 2023
    Report Date
    November 6, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FRN
    PMA / PMN Number
    K162165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED SERIAL NUMBER, (B)(6), IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ONE PIB-PCA (PATIENT-CONTROLLED ANALGESIA) PUMP, WITH BATTERY CAP AND STORAGE CAP WAS RECEIVED. NO OTHER COMPONENTS WERE RETURNED. THE RETURNED PUMP WAS INSPECTED IN A WELL-LIT AREA. THERE WERE NO VISIBLE CRACKS OR BREAKS ON THE PUMP BODY. THERE WAS NO VISIBLE DRIED MEDICATION OR FOREIGN MATERIAL. THE SENSOR COVER WAS RECEIVED IN PROPER POSITION OVER THE SENSOR, WITH NO VISIBLE DAMAGE OR DEBRIS. THERE WAS NO VISIBLE CORROSION OR DAMAGE IN THE BATTERY COMPARTMENT OR CAP. THE COILS APPEAR UNDAMAGED. ALL HISTORY INFORMATION WAS RETRIEVED AND RECORDED ON THE ATTACHED FORM. THE PUMP WAS RECEIVED IN PCA MODE. PROGRAMMING VERIFICATION WAS SUCCESSFULLY COMPLETED. DURING THE TEST, THE PUMP WAS NOT OBSERVED TO RUN CONTINUOUSLY. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 03-NOV-2023 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 ACTUAL DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 15-SEP-2023 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 06-OCT-2023 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

    FILL VOLUME: 200ML. FLOW RATE: 2ML/HR-10-ML/HR. (2ML PER HOUR, 5ML BOLUS ON A 1-HOUR LOCKOUT). PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED "THE AMBIT PUMP WAS PROGRAMMED TO INFUSE 2ML/HOUR OF ROPIVACAINE (PATEINT CARE ANESTHESIA) PCA. ONE OF THE WARD NURSE STAFF NOTICED THAT THE PUMP CONNECTED TO A PATIENT WAS CONTINUALLY INFUSING ROPIVACAINE ON A PCA PROGRAM. ONCE THE VOLUME INFUSED REACHED 10ML, THE NURSE STOPPED THE PUMP AND PLACED IT ON PAUSE. ONCE THEY RESTARTED THE PUMP, IT ONCE AGAIN CONTINUALLY INFUSED ROPIVACAINE ON A PCA PROGRAM. THE WARD NURSE CALLED THE [USER FACILITY] BUSINESS MANAGER FOR TROUBLESHOOTING. THEY RE-PROGRAMMED THE PUMP BUT HAD THE SAME OUTCOME. THE PUMP WAS DISCONTINUED FROM USE AND A NEW PUMP ATTACHED WHICH FUNCTIONED AS INTENDED."

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 11-SEP-2023 FROM DISTRIBUTOR STATING THE REPORTED INCIDENT IS "MOST LIKELY A USER ERROR". THE INFUSION HISTORY WAS CHECKED WITH THE FOLLOWING HISTORY APPEARING ON THE PUMP. * PCA PROGRAM. * 50.0ML TOTAL VOLUME INFUSED. * 3 TOTAL NUMBER OF BOLUSES DELIVERED. * 3 TOTAL NUMBER OF BOLUS REQUESTS. * 18HORS, 1MIN TOTAL ELAPSED TIME. THE INFUSION HISTORY NEARLY ALIGNS WITH THE PROGRAMMED INFUSION RATE, SEE BELOW: * WITH A 2ML/HR INFUSION RATE THE 18HR 1MIN ELAPSED TIME = 36.20ML TOTAL. * WITH THE 5ML BOLUS ON A 1HR LOCKOUT 3 BOLUSES DELIVERED = 15ML TOTAL. * TOTAL DELIVERY OF ROPIVACAINE = 51.20ML. * THE INFUSION HISTORY STATES 50.0ML TOTAL VOLUME WAS INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145432 AMBIT PAIN CONTROL SYSTEM, PIB/PCA ELECTRONIC INFUSION PUMPS & SYSTEMS FRN AVANOS MEDICAL INC. 220513 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown ROPIVACAINE