BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR

    MDR report key: 7986304 · Received October 19, 2018

    Report

    Report Number
    2026095-2018-00111
    Event Type
    Death
    Date Received
    October 19, 2018
    Date of Event
    September 28, 2018
    Report Date
    October 19, 2018
    Manufacturer
    AVANOS MEDICAL
    Product Code
    MEB
    UDI-DI
    30680651134760
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0202983490, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 17-OCT-2018 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).

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 09-NOV-2018 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).

    Description of Event or Problem · 1

    FILL VOLUME: 750 ML. FLOW RATE: 14 ML/HR. PROCEDURE: RIB FRACTURES. CATHPLACE: SUBPLEURAL NERVE BLOCK. IT WAS REPORTED THAT A PATIENT DIED ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. THE PATIENT WAS AN (B)(6) FEMALE PATIENT THAT HAD NINE RIB FRACTURES AFTER BEING INVOLVED IN A CAR ACCIDENT. SURGERY WAS PERFORMED ON THE PATIENT ON (B)(6) 2018. A CATHETER WAS PLACED ON THE SUBPLEURAL NERVE BLOCK FOR USE WITH AN ON-Q PUMP FOLLOWING THE SURGERY. THE PATIENT WAS REPORTED TO BE DOING WELL POST-OP. ON (B)(6) 2018 IT WAS NOTED THAT THE PATIENT'S OXYGEN LEVEL DESATURATED RAPIDLY AND WENT INTO PEA (PULSELESS ELECTRICAL ACTIVITY). THE PATIENT DIED WITH AN UNKNOWN CAUSE OF DEATH. NO DRUG LEVEL IN THE BLOOD WAS ASSESSED AND NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 19-OCT-2019 STATED THAT NURSE WHO WAS PRESENT DID NOT THINK THAT THE PATIENT HAD TYPICAL LOCAL ANESTHETIC TOXICITY FROM THE ON-Q PUMP. THE PATIENT WAS DECOMPENSATED ABOUT ONE HOUR BEFORE SHE STOPPED BREATHING. THE PATIENT EXHIBITED STROKE-LIKE SYMPTOMS, WEAKNESS IN THE ARM ON THE LEFT SIDE OF THE BODY. THE COMPUTED TOMOGRAPHY SCAN WAS CLEAR AND DID NOT SHOW ANY ISCHEMIC STROKE. THE PATIENT STOPPED BREATHING QUICKLY, HER CHEST TUBE CAME OUT, AND SHE WAS ALSO BLEEDING. THE ACTUAL CAUSE OF DEATH WAS NOT SHARED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825420 ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR ELASTOMERIC - SAF MEB AVANOS MEDICAL CB6004 0202983490 30680651134760

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death