BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q FIXED FLOW PUMP KITS WITH ON-Q SILVERSOAKER CATHETER

    MDR report key: 11590383 · Received March 30, 2021

    Report

    Report Number
    2026095-2021-00050
    Event Type
    Death
    Date Received
    March 30, 2021
    Date of Event
    September 9, 2020
    Report Date
    July 14, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 0002995060 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. DHR REVIEW FOUND FLOW ACCURACY TEST PERFORMED IN QUALITY LABORATORY WITHIN SPECIFICATION AND ABNORMAL CONDITIONS WERE NOT FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE PUMP WAS RECEIVED PARTIALLY FILLED. BOTH PINCH CLAMPS WERE IN PLACE AND CLOSED WITH NO BREAKAGE OBSERVED. THE TWO DISTAL MALE LUERS EACH HAD A FEMALE LUER ATTACHED, WITH THE TUBING ATTACHED TO THE FEMALE LUERS HAVING BEEN CUT. THE FEMALE LUERS WERE REMOVED PRIOR TO TESTING. THE PUMP WAS DRAINED OF MEDICATION AND FILLED TO NOMINAL VOLUME WITH 0.9% SALINE. INFUSION WAS NOT OBSERVED AND DRIED RESIDUE AND AIR BUBBLES WERE OBSERVED IN THE TUBING BETWEEN THE PUMP AND THE FILTER AS WELL AS IN THE TUBING PROXIMAL TO THE FLOW RESTRICTORS. STEPS WERE TAKEN TO CLEAR THE PUMP OF RESIDUE; HOWEVER IT WAS NOT POSSIBLE TO DISLODGE OR BREAK UP THE RESIDUE. AFTER ALL ATTEMPTS TO CLEAR THE TUBING AND FLOW RESTRICTORS TO ALLOW CONTINUATION OF TESTING, IT WAS DETERMINED THAT THE RESIDUE IN THE TUBING COULD NOT BE CLEARED AND THAT FUNCTIONAL TESTING COULD NOT BE PERFORMED ON THE RETURNED PUMP. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 13 JUL 2021 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

    INVESTIGATION REMAINS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 27 APR 2021 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

    ADDITIONAL INFORMATION RECEIVED 15-APR-2021 INDICATED THE PATIENT'S SURGERY WAS ON (B)(6) 2020 AND WAS A PANNICULECTOMY, INSURANCE BASED WITH ABDOMINOPLASTY, COSMETIC ADDED ON. THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT THE EVENING OF (B)(6) 2020 AFTER BEING FOUND DOWN AT HOME. THE PATIENT WAS ADMITTED TO THE ICU BUT EXPIRED THE MORNING OF (B)(6) 2020. FURTHER ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. ALL INFORMATION REASONABLY KNOWN AS OF 30 MAR 2021 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: 4 ML/HR. PROCEDURE: ABDOMINOPLASTY. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A PATIENT HAD AN ABDOMINOPLASTY BACK IN (B)(6) 2020 AND THE DEVICE WAS USED. THE PATIENT WAS DISCHARGED THE SAME DAY, BUT WAS RE-ADMITTED THE FOLLOWING DAY FOR COMPLICATIONS AND SUBSEQUENTLY DIED. ACCORDING TO THE USER FACILITY, THE AUTOPSY REPORT WAS RECENTLY RELEASED AND "BUPIVACAINE TOXICITY WAS TO BLAME." THE FLOW RATE OF BUPIVACAINE WAS 4 ML/HR AND THE CONCENTRATION WAS 0.25%. EXACT DATE OF DEATH WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488319 ON-Q FIXED FLOW PUMP KITS WITH ON-Q SILVERSOAKER CATHETER ELASTOMERIC LFR MEB AVANOS MEDICAL INC. PM048-A 0002995060

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death 0.25% BUPIVACAINE| 0.25% BUPIVACAINE