BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDI-VAC ® FLEX ADVANTAGE® - 1000 ML

    MDR report key: 6980638 · Received October 26, 2017

    Report

    Report Number
    1423537-2017-00136
    Event Type
    Death
    Date Received
    October 26, 2017
    Date of Event
    October 4, 2017
    Report Date
    December 11, 2017
    Manufacturer
    CARDINAL HEALTH MALTA 212 LTD
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS AWAITING FURTHER CLARIFICATION OF THE REPORT FROM THE END USER CUSTOMER. A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT FILED ON 10/26/2017. ADDITIONAL INFORMATION RECEIVED FROM THE END USER CUSTOMER. THE INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS COMPLETED. TO INVESTIGATE THE CONCERN, ON 7 NOVEMBER 2017, OUR QA MANAGER, RA MANAGER AND SALES MANAGER OF CARDINAL HEALTH VISITED (B)(6) HOSPITAL. THEY MET WITH THE PHARMACIST OF THE (B)(6) WHO IS RESPONSIBLE FOR THE VIGILANCE. AFTER AN INITIAL MEETING WITH THE PHARMACIST, WE HAVE CONCLUDED THAT THE ASSIGNABLE ROOT CAUSE IS RELATED TO IMPROPER SET-UP OF THE FLEX ADVANTAGE SYSTEM. THE PHARMACIST CONFIRMED THAT THE REUSABLE HARD CANISTER ¿ON / OFF¿ VALVE WAS SET IN THE ¿OFF¿ POSITION WHICH CAUSED THE NON-FUNCTION OF THE UNIT. THE PHARMACIST CONFIRMED THAT THE REUSABLE HARD CANISTER WITH INSERTED LINER WAS ALSO PLACED ON THE FLOOR AND NOT ATTACHED TO A WALL MOUNT OR IN A ROLL STAND AS ILLUSTRATED IN THE IFU. SHE CONFIRMED THAT THEIR PERSONNEL FOLLOWED THE MEDLINE ¿QUICK REFERENCE¿ ONE PAGER WHICH DOES NOT ILLUSTRATE THE WARNING INFORMATION AND DOES NOT MENTION THAT THE DEVICE SHOULD BE ATTACHED TO A WALL MOUNT OR IN A ROLL STAND AS ILLUSTRATED ON THE CARDINAL HEALTH IFU. AS SET OUT AMONG THE WARNINGS IN THE IFU, PREMATURE SHUT OFF MAY OCCUR IF THE REUSABLE HARD CANISTER IS BUMPED OR MOVED SUDDENLY IN A VERTICAL POSITION, THEREFORE THE DEVICE SHOULD BE PLACED IN VERTICAL POSITION AT ALL TIMES. NEVERTHELESS BOTH THE ¿QUICK REFERENCE¿ ONE PAGER AND THE PRODUCT IFU ILLUSTRATE THAT THE REUSABLE HARD CANISTER ¿ON / OFF¿ VALVE SHOULD BE IN THE ¿ON¿ POSITION AT ALL TIMES WHILE OPERATING THE DEVICE. A REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. HOWEVER BASED ON THE INVESTIGATION, WE HAVE CONCLUDED THAT THE MEDI VAC FLEX ADVANTAGE LINERS ARE FREE OF DEFECTS OR FUNCTIONAL PROBLEMS. TRENDING OF PAST PRODUCT QUALITY REPORTS INDICATE THAT THIS REPORTED INCIDENT IS ISOLATED TO (B)(6) ONLY. THUS AS A PREVENTIVE ACTION, CARDINAL HEALTH ISSUED A FIELD SAFETY NOTICE TO CUSTOMERS BASED IN (B)(6) EMPHASIZING THE LANGUAGE AND WARNINGS STATED IN THE PRODUCT IFU AND THE RISKS ASSOCIATED WITH INCORRECT USE OF THE DEVICE. THE (B)(6) QUICK REFERENCE NOTE WILL BE UPDATED TO THE CARDINAL HEALTH QUICK REFERENCE GUIDE TO ENSURE THERE WILL BE NO REPEAT EVENTS. WE WILL CONTINUE TO MONITOR TRENDS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: AFTER A VASCULAR THROMBECTOMY PROCEDURE, A (B)(6) PATIENT PRESENTED A COMPARTMENT SYNDROME 1 DAY POST-OP, AND SYNDROMES OF DIGESTIVE OCCLUSION 2 DAYS POST-OP. AT 7:00PM, THE PATIENT SUFFERED RESPIRATORY ARREST WITH IMPORTANT VOMITING. THE DOCTOR INTENDED TO PERFORM A BRONCHO-ASPIRATION USING THE MEDIC-VAC SYSTEM AND IT WAS IMPOSSIBLE: THE SYSTEM DID NOT WORK. THE DOCTOR USED A SECOND MEDI-VAC SYSTEM ON A TROLLEY AND THE ASPIRATION WORKED. CONSEQUENCES: DELAY IN TAKING-OVER THE PATIENT. IT WAS IMPOSSIBLE TO PERFORM A VENTILATION DUE TO THE IMPOSSIBILITY TO DO THE ASPIRATION IN A TIMELY MANNER. THE PATIENT DIED. CONSERVATIVE ACTIONS TAKEN BY THE HOSPITAL: THE WALL FIXATION HAS BEEN CHECKED BY THE QUALIFIED TECHNICIANS AND SEEMED TO BE WORKING PROPERLY. REVIEW OF THE DEVICES USED DURING THE REANIMATION: THE MEDI-VAC SYSTEM IS USED WITHOUT A TROLLEY. THE ¿QUICK NOTICE¿ PROVIDED BY THE MANUFACTURER DOES NOT MENTION SUCH ASPECTS. AN INFORMATION HAS BEEN CIRCULATED TO ALL THE SERVICES IN THE HOSPITAL TO REMIND THE GOOD INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761166 MEDI-VAC ® FLEX ADVANTAGE® - 1000 ML APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CARDINAL HEALTH MALTA 212 LTD 65651910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death