BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP WITH SELECT-A-FLOW

    MDR report key: 10089381 · Received May 26, 2020

    Report

    Report Number
    2026095-2020-00067
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    May 5, 2020
    Report Date
    August 26, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    10680651134728
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 2968464 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 18 JUN 2020 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 COMP (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

    PHOTOS WERE PROVIDED AND CONFIRMED A REACTION WAS OBSERVED IN THE CUSTOMER'S SKIN. ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, BASED ON THE USE REVIEW, THE REACTION OBSERVED CAN BE A NECROSIS CAUSED BY THE COMBINATION OF DRUGS THAT THE SURGEON USED AS A TRIAL. ALL INFORMATION REASONABLY KNOWN AS OF 26 AUG 2020 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 27-MAY-2020 INDICATED THE PATIENT'S INFUSION BEGAN (B)(6) 2020 1730 AND ENDED (B)(6) 2020 1730. BLISTERS WERE NOTICED ON (B)(6) 2020 AND NECROSIS DEVELOPED LATER, DATE UNKNOWN. THE CATHETER WAS AN EPIDURAL CATHETER, BRAND UNKNOWN. TOTAL FILL VOLUME OF THE PUMP WAS 400ML AND IT WAS SET TO A FLOW RATE OF 8ML/HR. PATIENT RECEIVED GENERAL ANESTHESIA PLUS BLOCK. CATHETER LOCATION WAS "MEDIAL FEMORAL CONDYLE, TIP TUCKED POSTERIOR OF THE KNEE." SURGEON NOTED THE INCIDENT. PATIENT NEEDED A "SKIN GRAFT AND PLASTIC SURGEON PRESENCE." THE PATIENT WAS AMBULATORY WHILE USING THE PUMP. PATIENT'S CURRENT CONDITION WAS LISTED AS "REPAIR SURGERY HAS OCCURRED." ADDITIONAL INFORMATION RECEIVED 02-JUN-2020 INDICATED THE PUMP WAS FILLED AND PRIMED ACCORDING TO THE INSTRUCTIONS FOR USE. THE SURGEON WANTED TO TRIAL ADDING THE FOUR DRUGS MENTIONED IN THE INITIAL REPORT [TRANEXAMIC ACID, ADRENALINE, CELESTONE, KETOROLAC ] TO THE LOCAL ANESTHETIC IN THE PUMP TO SEE IF THIS IMPROVED THE PATIENT OUTCOME. THE HOSPITAL HAD TWO SURGEONS USING THE ON-Q PUMPS PRIOR TO THIS SURGEON'S TRIAL. STAFF WAS TRAINED. PATIENT WAS A NEW USER OF THE PUMP. THE SURGEON STATED HE "STITCHES [STITCHES] AND CLOSES THE JOINT CAPSULE TIGHTLY WHICH WOULD REDUCE THE CHANCE OF LEAKAGE IF THE FLOW RATE IS TOO HIGH."

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 26 MAY 2020 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2020-00066 FOR THE FIRST REPORT. FILL VOLUME: 400 ML, FLOW RATE: UNKNOWN, PROCEDURE: TOTAL KNEE REPLACEMENT, CATHPLACE: KNEE, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT TWO "PATIENTS DEVELOPED BLISTERS AROUND THE KNEE, ON THE SKIN, OF THEIR LEG WHICH HAD A TOTAL KNEE REPLACEMENT SURGERY. BOTH OF THESE PATIENTS HAD ONE OF THEIR BLISTERS BECOME NECROTIC. THE PUMPS WERE FILLED WITH 400ML 0.2% ROPIVACAINE, PLUS FOUR OTHER DRUGS THE SURGEON WAS TRIALLING AS A MIX. THE OTHER DRUGS: 1G TRANEXAMIC ACID, 1:1000 ADRENALINE IN 1ML AMPULE, 5.7MG CELESTONE IN 1ML AMPULE, 1ML AMPULE OF KETOROLAC." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552717 ON-Q PUMP WITH SELECT-A-FLOW ELASTOMERIC - SAF MEB AVANOS MEDICAL - IRVINE CB004 2968464 10680651134728

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other 1:1000 ADRENALINE IN 1ML AMPULE| 1G TRANEXAMIC ACID| 1ML AMPULE OF KETOROLAC| 5.7MG CELESTONE IN 1ML AMPULE