BEUDAMED
    FDA Adverse Event Malfunction 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: 7962490 · Received October 12, 2018

    Report

    Report Number
    2026095-2018-00107
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Report Date
    December 4, 2018
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651134777
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0202343060, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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). 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

    ONE SAMPLE DEVICE WAS EVALUATED. THE PUMP WAS RECEIVED EMPTY AND USED. INFUSION WAS VERIFIED ON ALL THE FLOW RATES AND IT FLOWED. THE INVESTIGATION SUMMARY CONCLUDED THAT A FAST FLOW WAS NOT OBSERVED FOR THE PUMP. THE PUMP MET SPECIFICATIONS FOR BOTH THE FLOW ACCURACY AND PRESSURE POT TESTS. THE ROOT CAUSE WAS INCORRECT USE. AFTER REVIEWING THE DHR AND USE CONDITIONS, IT WAS CONCLUDED THAT THE PUMP WAS USED BEYOND ITS SHELF LIFE. THAT CONDITION MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE INCIDENT DATE IS 20-SEP-2018 AND LOT EXPIRED ON 30-JUN-2018. ALL INFORMATION REASONABLY KNOWN AS OF 19-DEC-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). 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 (B)(6) 2018 NOTED THE PUMP INFORMATION AS FOLLOWS:A 750ML DUAL PUMP DEVICE WAS DISPENSED FROM THE PHARMACY AT 1102 ON (B)(6) 2018. THE PUMP WAS CONNECTED TO THE PATIENT AT 1144 AT DUAL RATES OF 6ML/HR. AT 2000 ON (B)(6) 2018 BOTH RATES WERE INCREASED TO 7ML/HR. A CALL AROUND 1015 ON (B)(6) 2018 NOTED THAT THE PUMP WAS ALMOST EMPTY.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: BILATERAL TAP. IT WAS REPORTED THE NURSE FROM THE ANESTHESIA GROUP AT THE HOSPITAL REPORTED THAT SHE SUSPECTS A PUMP INFUSED QUICKER THAN EXPECTED ON A PATIENT. THE PATIENT HAD BILATERAL TAP CATHETERS PLACED ON (B)(6) 2018. THERE WAS NO REPORTED PATIENT INJURY. THE EXACT TIME OF WHEN THE PUMP WAS STARTED OR WHEN THE INFUSION ENDED WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802617 ON-Q C-BLOC WITH DUAL SELECT-A-FLOW* 600 ML X 1-7 ML/HR + 1-7 ML/HR ELASTOMERIC - SAF MEB HALYARD - IRVINE CB6007 0202343060 30680651134777

    Patients

    Seq Age Sex Outcome Treatment
    1 0.125% BUPIVACAINE