BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q C-BLOC WITH DUAL SELECT-A-FLOW 600 ML X 1-7 ML/HR + 1-7 ML/HR

    MDR report key: 7955760 · Received October 11, 2018

    Report

    Report Number
    2026095-2018-00110
    Event Type
    Death
    Date Received
    October 11, 2018
    Report Date
    December 12, 2018
    Manufacturer
    AVANOS MEDICAL
    Product Code
    MEB
    UDI-DI
    10680651134773
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 10-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

    CORRECTED DATA- TYPE OF REPORTABLE EVENT. ALL INFORMATION REASONABLY KNOWN AS OF 07-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. 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: UNKNOWN. FLOW RATE: 12 ML/HR (6 ML PER SIDE). PROCEDURE: BI-LATERAL NEPHRECTOMY. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT DIED. IT WAS A PEDIATRIC PATIENT THAT HAD AN ON-Q ELASTOMERIC PUMP PLACED. THE HOSPITAL DOES NOT CONFIRM THAT THE ON-Q ELASTOMERIC PUMP IS RESPONSIBLE, BUT IS CONSIDERING LOCAL ANESTHETIC TOXICITY AS A POTENTIAL CAUSE. THE PUMP WAS NOT SAVED BECAUSE IT WAS DISCONNECTED SEVERAL HOURS PRIOR TO PATIENT DEATH. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795796 ON-Q C-BLOC WITH DUAL SELECT-A-FLOW 600 ML X 1-7 ML/HR + 1-7 ML/HR ELASTOMERIC - SAF MEB AVANOS MEDICAL CB6007 UNKNOWN 10680651134773

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death