BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10402505 · Received August 13, 2020

    Report

    Report Number
    2026095-2020-00110
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 13, 2020
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    MEB
    UDI-DI
    00193494134723
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODE: METALLIC TASTE IN HIS MOUTH, LIGHTHEADEDNESS, HEAD PRESSURE, FEELING OFF WHEN STANDING-UP, AND LOSS OF APPETITE. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 10-AUG-2020 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: 550 ML. FLOW RATE: 8 ML/HR. PROCEDURE: BICEP TENDINOSIS REPAIR. CATHPLACE: UNKNOWN. DATE OF PROCEDURE: (B)(6) 2020. IT WAS REPORTED ON (B)(6) 2020, "A PATIENT WHO HAS A BICEP TENDINOSIS REPAIR DONE ON (B)(6) 2020 REPORTED A GRADUAL ONSET OF METALLIC TASTE IN HIS MOUTH, LIGHTHEADEDNESS, HEAD PRESSURE, FEELING OFF WHEN HE STOOD UP, AND LOSS OF APPETITE. (B)(6) 2020, THE THIRD DAY WITH THE PUMP RUNNING AT 8 ML/HR (PATIENT DID NOT ADJUST THE RATE, ALTHOUGH HE DID HAVE A SAF)." THE PATIENT FELT THE WORST HE HAD OVER THE COURSE OF THE 3-DAYS ON (B)(6) 2020. THE PATIENT HAD ALREADY CLAMPED OFF THE PUMP WHEN HE CALLED ME. THE PATIENT WAS ADVISED TO CONTACT THE ON-CALL ANESTHESIOLOGIST RIGHT AWAY AND REPORT HIS SYMPTOMS. THE PATIENT WAS UNABLE TO REACH THE PHYSICIAN. THE PHYSICIAN TOLD THE PATIENT TO REMOVE THE CATHETER ON THE 3RD DAY. EVENTUALLY, THE PATIENT HAD REACHED THE PHYSICIAN WHO ADVISED HIM TO DISCONTINUE THE PUMP, DRINK WATER, AND MONITOR THE SYMPTOMS AND CALL BACK IF IT HAD GOTTEN WORSE. "PATIENT REPORTED FEELING MORE CLEAR HEADED EVER SINCE THE PUMP WAS CLAMPED OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866701 ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR ELASTOMERIC - SAF MEB AVANOS MEDICAL, INC. CB004 UNKNOWN 00193494134723

    Patients

    Seq Age Sex Outcome Treatment
    1 Other