BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8668

    MDR report key: 7706091 · Received July 20, 2018

    Report

    Report Number
    9616031-2018-00006
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Report Date
    August 17, 2018
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). ADDITIONAL INFORMATION WILL BE PROVIDED WITH THE CONCLUSIONS 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). WHEN REVIEWING REPORTABLE EVENTS FOR THE SAME ISSUE WE HAVE BEEN ABLE TO FIND TWO COMPLAINTS IN TOTAL. BOTH COMPLAINTS HAVE BEEN REGISTERED FOR THE SAME CUSTOMER AND INCLUDED ALLEGATION ABOUT PATIENT CANCELLATION DUE TO THE RESIDUES FOUND ON THE LOAD. DUE TO THE FACT THAT WE WERE NOT ABLE TO ESTABLISH WHAT KIND OF TREATMENT HAS BEEN CANCELLED WE HAVE TAKEN INTO THE CONSIDERATION THAT IT COULD HAVE BEEN A NONE SCHEDULE TYPE OF TREATMENT WHICH, WHEN DELAYED, CAN CAUSE AN IMMEDIATE DANGER FOR THE PATIENT THUS COULD CAUSE A SERIOUS INJURY OR WORSE UPON THE RE-OCCURRENCE. THE PRODUCT INVOLVED IN THE INCIDENT IS A 86-SERIES WASHER DISINFECTORS WITH SERIAL NUMBER: (B)(4) MANUFACTURED ON 13TH OF MARCH 2017.DHR OF THE DEVICE WAS REVIEWED AND IT DID NOT PROVIDE ANY RELEVANT INFORMATION. THERE WAS NO ANOMALIES DETECTED DURING THE MANUFACTURING PROCESS. FROM THE ORIGINAL DESCRIPTION OF THE ISSUE, PROVIDED BY THE CUSTOMER TO THE GETINGE REPRESENTATIVE WE CAN CONCLUDE THAT LABORATORY ANALYSIS OF THE WHITE PARTICLES WAS DONE AND DID NOT PROVIDE ANY CONCLUSIVE PROOF OF MATERIAL MAKE UP. MOREOVER, THE IN LINE FILTERS WERE FITTED IN CASE THE ISSUE WAS RELATED TO WATER SUPPLY BUT DID NOT SOLVE THE ISSUE. IT HAS BEEN CONCLUDED THAT THE ISSUE IS NOT CONNECTED WITH THE WATER QUALITY . ALTHOUGH THERE WAS NO ACTUAL MALFUNCTION FOUND WITH THE DEVICE, THE MANUFACTURER'S TECHNICAL SUPPORT RECOMMENDED INSPECTION OF ADDITIONAL PARTS AND MINOR IMPROVEMENTS TO ADDRESS THE ISSUE. AFTER IMPLEMENTATION OF THOSE, THE TECHNICIAN PERFORMED THE TEST OF THE DEVICE (RUNNING A CYCLE WITH THE BASKET WITHOUT ANY INSTRUMENTS IN IT) AND NO RESIDUES WERE OBSERVED. USER MANUAL FOR 86-SERIES (6001300302, REV. I) INCLUDE INFORMATION ABOUT FACTORS WHICH COULD IMPACTED THE RESULTS OF CLEANING AND IS LISTING FOLLOWING: TYPE OF GOODS; LEVEL OF DIRTINESS; CHOOSE OF DETERGENT; WATER QUALITY; WATER TEMPERATURE; ADDITIONALLY, IN SECTION 3.2.2. HANDLING AND PLACEMENT OF GOODS OF THE MENTIONED ABOVE USER MANUAL INCLUDES INFORMATION THAT GOOD MAY NEED TO BE PRETREATED TO ACHIEVE SUFFICIENT CLEANING. GOING FURTHER IN SECTION 3.5.1. UNLOADING GOODS INCLUDES INFORMATION ABOUT VISUAL INSPECTION OF THE CLEANING RESULTS WHICH NEEDS TO BE PERFORMED DURING UNLOADING OF THE WASHER DISINFECTOR. BASED ON THE FINDINGS FROM THE CUSTOMER SITE AND ALSO ON THE INFORMATION PROVIDED IN PROPER USER MANUAL IT SEEMS THAT THE MOST PROBABLY ROOT CAUSE OF THE ISSUE IS USER ERROR. IT SEEMS THAT THE INSTRUMENTS WERE NOT RINSED OR WASHED OUT ENOUGH BEFORE PLACING THE LOAD IN THE WASHER, THUS THE RESIDUES WERE FOUND AFTER COMPLETION OF THE DISINFECTION PROCESS IN THE WASHER. IN SUMMARY, BASED ON ALL COLLECTED DATA WE CONCLUDED THAT THE DEVICE HAS NOT FAILED TO MEET THE MANUFACTURER SPECIFICATION, BUT PERFORMED NOT AS INTENDED. THE MANUFACTURER HAS RECOMMENDED TO THE CUSTOMER TO INCREASE THE TIME OF PRE-RINSE FROM 4 MINUTES TO 5 MINUTES AND TO INCREASE WASH-TIME AT 55`C FROM 5 MINUTES TO 10 MINUTES. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THIS COMPLAINT IS CONSIDERED TO BE ISOLATED TO ONE CUSTOMER ONLY, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2017 WE BECAME AWARE OF AN ISSUE WITH ONE OF GETINGE DISINFECTION AB DEVICES- 86-SERIES. AS STATED BY THE CUSTOMER, WHITE RESIDUE IS FOUND ON THE FINISHED WASH RACKS AND INSTRUMENTS. ON (B)(6) 2018 WE HAVE RECEIVED A USER REPORT FROM MHRA WHERE THE CUSTOMER STATED THAT THERE WAS A DELAY IN TREATMENT. DUE TO THE LIMITED INFORMATION RELATED TO KIND OF TREATMENT THAT WAS POSTPONED WE DECIDED TO REPORT IT BASED ON THE POTENTIAL AS ANY PARTICLE LEFT IN THE CHAMBER COULD BE A SOURCE OF CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548219 8668 MEC MEC GETINGE DISINFECTION AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other