BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    86-SERIES

    MDR report key: 14693304 · Received June 15, 2022

    Report

    Report Number
    9616031-2022-00013
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 30, 2022
    Report Date
    June 15, 2022
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ON 30TH MAY, 2022, GETINGE BECAME AWARE OF AN ISSUE WITH 8666 WASHER-DISINFECTORS WITH THE CATALOG NUMBER S-8666913-CTOM AND THE SERIAL NUMBER (B)(6), MANUFACTURED ON 2ND MAY, 2011. WITH THE INITIAL ALLEGATION WE RECEIVED INFORMATION THAT THE CUSTOMER FOUND OUT DURING THE DAILY INSPECTION THAT THE UNIT IS NOT DOSING THE ENZYME. ENZYMATIC DETERGENT IS DEDICATED FOR GENERAL CLEANING OF SURGICAL INSTRUMENTS AND UTENSILS. IT IS USED WITH AUTOMATED WASHERS AND DESIGNED TO PENETRATES AND BREAKS DOWN PROTEIN AND ORGANIC MATTER. AT THIS POINT, IT WAS STATED NO VISUAL CHECKS WERE PERFORMED ON EACH LOAD AND THE CUSTOMER DID NOT PERFORM ANY ADDITIONAL LOAD TESTING. WITH THE COMPLAINT AT HAND THERE WAS NO ALLEGATION ABOUT ANY ADVERSE OUTCOME, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL, THAT ANY IMPROPER CLEANED INSTRUMENTS, AS A RESULT OF DETERGENTS NOT DOSED CORRECTLY DURING THE PROCESS, COULD BE USED TO THE PATIENTS¿ TREATMENT AND LEAD TO THE CROSS-INFECTION. ON 22ND JUNE, 2022 WE RECEIVED INFORMATION THAT THE INSTRUMENTS PROCESSED WITH NO ENZYMATIC DETERGENT ADDED WERE REPROCESSED BY THE CUSTOMER. BASED ON THE INFORMATION WE CONCLUDED THAT THE EVENT IN FACT IS NOT SAFETY RELATED DURING INVESTIGATION COURSE IT WAS CONFIRMED THAT THE AGING PERISTALTIC PUMP HOSE COULD NOT HAVE PUMPED THE ENZYME LIQUID TO THE WASHER DISINFECTOR. ACCORDING TO USER MANUAL IT IS RECOMMENDED TO VISUALLY INSPECT THE ITEMS AFTER UNLOADING. AFTER THE HOSE WAS REPLACED BY SERVICE TECHNICIAN THE DEVICE WAS RETURNED TO USE IN FULLY OPERATIONAL STATE. BASED ON THE INFORMATION GATHERED THE HOSE COULD HAVE FAILED AS A RESULT OF PROLONGED USAGE. THE INVESTIGATION COURSE SHOWS THAT THE DEVICE¿S SERVICE MANUAL IS INSTRUCTING THE SERVICE TECHNICIAN WHAT ACTIONS SHOULD BE TAKEN DURING THE PREVENTIVE MAINTENANCE. MOST LIKELY, THE PREVENTIVE MAINTENANCE SCHEDULE WAS NOT FOLLOWED AND THE PERISTALTIC PUMP HOSE WAS NOT REPLACED IN LINE WITH THE REQUIREMENTS. AS THE PREVENTIVE MAINTENANCE WAS NOT PERFORMED BY SERVICE TECHNICIAN IN LINE WITH INSTRUCTIONS GIVEN AND PERISTALTIC PUMP HOSE WAS NOT REPLACED ON TIME IT DIRECTLY LED TO THE DOSING ISSUE. THIS IS WHY THE MOST LIKELY ROOT CAUSE IN THIS PARTICULAR CASE HAS BEEN ESTABLISHED AS SERVICE ISSUE. IT WAS CONFIRMED THAT WHEN THE EVENT OCCURRED, THE DEVICE WAS DIRECTLY INVOLVED AND DID NOT MEET ITS SPECIFICATION, AS ENZYMATIC DETERGENT WAS NOT DOSED. WE HAVE NOT RECEIVED INFORMATION WHETHER THE DEVICE WAS BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS AT THE TIME WHEN THE EVENT OCCURRED. NEVERTHELESS, DURING THE INVESTIGATION WE WERE ABLE TO CONFIRM THAT THE INSTRUMENTS CLEANED WITHOUT ADDING THE ENZYMATIC DETERGENT WERE REPROCESSED. THEREFORE, WE CAN CONCLUDE FROM THE INVESTIGATION THAT THE ISSUE IS NOT SAFETY-RELATED AND CAN ONLY CAUSE AN INCONVENIENCE ON THE CUSTOMER. THE PURPOSE OF THIS SUBMISSION IS ALSO TO PROVIDE A CORRECTION OF THE SECTION H4. DEVICE MANUFACTURE DATE. THIS IS BASED ON THE RESULT OF AN INTERNAL REVIEW NOTING THE INITIAL REPORT WAS INCORRECTLY SUBMITTED STATING ANOTHER MANUFACTURE DATE. PREVIOUS PROVIDED H4. DEVICE MANUFACTURE DATE: 2011-05-27. CORRECTED H4. DEVICE MANUFACTURE DATE: 2011-05-02.

    Description of Event or Problem · 0

    ON 30TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH THE 86-SERIES WASHER DISINFECTOR WITH THE MODEL NAME 8666. AS IT WAS STATED, THE AGING PERISTALTIC PUMP HOSE CANNOT PUMP THE ENZYME LIQUID TO THE WASHER DISINFECTOR. THERE WAS NO ALARM ON THE DEVICE. WE CONFIRMED THAT THE CUSTOMER FOUND THE PROBLEM DURING THE DAILY INSPECTION AS THE AMOUNT OF ENZYMATIC DETERGENT HAS NOT DECREASED SINCE THE PREVIOUS DAY. THE CUSTOMER DOES NOT PERFORM VISUAL CHECKS OF THE PROCESSED LOADS AS RECOMMENDED BY THE MANUFACTURER IN THE USER MANUAL. THERE WAS NO INJURY REPORTED, NEVERTHELESS WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS NON-PROPERLY CLEANED GOODS COULD BE USED TO PATIENT TREATMENT AND COULD BE A SOURCE OF CROSS-INFECTION.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156923 86-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 8666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown