BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESET PCA PUMP

    MDR report key: 14635564 · Received June 8, 2022

    Report

    Report Number
    1722214-2022-00005
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 12, 2022
    Report Date
    November 17, 2022
    Manufacturer
    SUMMIT MEDICAL PRODUCTS, INC.
    Product Code
    FRN
    UDI-DI
    00857595005817
    PMA / PMN Number
    K052221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 07-JUN-2022 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). THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, D829812, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND WAS PROCESSED FOR EVALUATION. A PUMP AND CASSETTE WAS RETURNED, THE VOLUMETRIC, TIMING, AND SIMULATED USE TEST WERE WITHIN SPECIFICATIONS. NO DEFECTS NOTED AND NO ALARMS OCCURRED DURING THE TEST. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 10-NOV-2022 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: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: TOTAL SHOULDER. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT 'STATES THAT AFTER 8-HOURS OF THE PUMP RUNNING. THE PUMP SEEMED LIKE IT WAS RUNNING TOO FAST. THE PATIENT'S ARM WAS COMPLETELY NUMB AND TINGLING...THEN IT BECAME RED AND SWOLLEN.' THE DOCTOR HAD THE FAMILY MEMBER TURN OFF THE PUMP AND REMOVE THE CATHETER FROM THE PATIENT. THE PUMP WAS DISCONTINUED WITHOUT DIFFICULTY. PATIENT CURRENTLY EXPERIENCING PAIN AT AN '8' ON THE 1-10 PAIN SCALE WITH '10' BEING THE WORST PAIN. TAKING 2 OXYCODONE TABLETS BY MOUTH EVERY 4-6 FOR PAIN CONTROL. ENCOURAGED PATIENT TO ICE SHOULDER FOR POST OP PAIN CONTROL. REDNESS, SWELLING, NUMBNESS AND TINGLING HAVE ALL RESOLVED. PATIENT DENIED EVER EXPERIENCING A FEVER, METALLIC TASTE IN THE MOUTH, OR ANY RINGING IN THE EARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599929 PRESET PCA PUMP ELECTRONIC INFUSION PUMPS & SYSTEMS FRN SUMMIT MEDICAL PRODUCTS, INC. 220534 D829812 00857595005817

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female ROPIVACAINE