BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    86-SERIES

    MDR report key: 7343190 · Received March 15, 2018

    Report

    Report Number
    9616031-2018-00002
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 21, 2018
    Report Date
    July 9, 2018
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTIC AMERICA, LLC, (REGISTRATION NO. 3012092534). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTIC AMERICA, LLC, (REGISTRATION NO. 3012092534). THE EVENT IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. (B)(4)) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTIC AMERICA, LLC, (REGISTRATION NO. (B)(4)). THE PRODUCT INVOLVED IN THE INCIDENT IS A 86-SERIES WASHER DISINFECTOR WITH SERIAL NUMBER (B)(4). ACCORDING TO INFORMATION PROVIDED IN THE COMPLAINT IT WAS INSTALLED ON (B)(6) 2002, THEREFORE IT WAS IN USE AT LEAST 16 YEARS BEFORE THE INCIDENT TOOK PLACE. WHEN REVIEWING SIMILAR REPORTABLE EVENTS IN THE CORPORATE COMPLAINT HANDLING SYSTEM WE WERE ABLE TO FIND AN ADDITIONAL COMPLAINT OF THIS KIND, HOWEVER BOTH OF THEM WERE REPORTED AT THE SAME TIME BY THE SAME CUSTOMER. THEREFORE WE CONCLUDE THE ISSUE TO BE ISOLATED AND LIMITED TO ONE CUSTOMER AND ONE INSTANCE ONLY. THE ISSUE HAS BEEN INVESTIGATED BY MANUFACTURING SITE. IT HAS BEEN ESTABLISHED THAT WHEN THE DEVICE WAS MANUFACTURED THERE WERE NO STANDARDS WHICH SPECIFIED REQUIREMENTS FOR FLOW MONITORING. DUE TO THIS ALL DEVICES RELEASED ON THE MARKET AT THAT TIME WERE DESIGNED WITH "EMPTY CAN" ALARM WHICH IS TRIGGERED WHEN THE DEVICE RUNS OUT OF DETERGENT. IN SUCH SITUATION, THE DEVICE WOULD DISPLAY AN ALARM ON THE OPERATING PANEL. THE UNIT STOPS WORKING UNTIL THE OPERATOR FILL THE CONTAINER FOR THE DETERGENT AND RESET THE DEVICE. ADDITIONALLY, THE USER MANUAL CURRENT AT THE TIME WHEN THE DEVICE WAS MANUFACTURED (SERIAL NO. (B)(4)) INCLUDES INFORMATION ABOUT DAILY ROUTINE WHICH SHOULD BE TAKEN BY THE CUSTOMER AND IT INDICATES THAT DETERGENT/RINSE AID CONTAINERS SHOULD BE CHECKED FOR PRESENCE OF THE MENTIONED LIQUIDS. AT THE CASE AT HAND IT WAS DISCOVERED THAT THE ROOT CAUSE OF THE ISSUE WAS CONNECTED WITH THE MALFUNCTIONED PUMP, WHICH FAILED AND DID NOT RETRIEVE THE DETERGENT DURING THE CYCLE. BASED ON ALL INFORMATION GATHERED FOR THIS SPECIFIC CASE WE WERE ABLE TO ESTABLISH THAT WHEN THE EVENT OCCURRED THE DEVICE WAS NOT UP TO THE SPECIFICATION, FORTUNATELY THERE WAS NO ADVERSE OUTCOME REPORTED. WE DECIDED TO REPORT THIS COMPLAINT BASED ON THE POTENTIAL RELATED WITH LACK OF DETERGENT INTAKE AND POSSIBILITY THAT THIS SITUATION COULD LAST FOR SOME TIME BEFORE IT WAS DISCOVERED BY THE USER DUE TO LACK OF PREVENTIVE MAINTENANCE. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THE ISSUE SEEMS TO BE AN ISOLATED CASE, GETINGE WILL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. (B)(4) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTIC AMERICA, LLC, (REGISTRATION NO. (B)(4). THE EVENT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION (B)(4), (B)(4). THE EVENT IS BEING INVESTIGATED BY MANUFACTURING SITE. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY GETINGE REPRESENTATIVE THAT DURING PREVENTIVE MAINTENANCE PERFORMED ON THE DEVICES LOCATED AT CUSTOMER SITE IT HAS BEEN FOUND THAT NO DETERGENT WAS TAKEN DURING THE CYCLE. IT HAS BEEN ALSO FOUND THAT PREVIOUS MAINTENANCES WERE PERFORMED BY CUSTOMER ITSELF. NO INFORMATION ABOUT ANY INJURY HAS BEEN REPORTED, HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183514 86-SERIES MEC MEC GETINGE DISINFECTION AB 8668

    Patients

    Seq Age Sex Outcome Treatment
    1 Other