BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAKO COVERSTAINER

    MDR report key: 17278163 · Received July 7, 2023

    Report

    Report Number
    3003423869-2023-00084
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 9, 2023
    Report Date
    June 24, 2024
    Manufacturer
    AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
    Product Code
    KPA
    UDI-DI
    05700571112571
    Removal / Correction Number
    Z-1919-2024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION THAT RECALL REFERENCE NUMBER, (B)(4), HAS BEEN RECEIVED. AGILENT TECHNOLOGIES RECALL, REFERENCE NUMBER (B)(4), HAS BEEN INITIATED APRIL 2024 WITH THE SCOPE OF NOTIFYING ALL COVERSTAINER CUSTOMERS OF THE FOLLOWING ISSUE: THE LOWER DOOR THAT OPENS TO THE REAGENT BOTTLES IS CRACKING AND/OR BREAKING OFF IN THE UPPER CORNER OF THE PLEXIGLASS. CAPA01211 HAS ADDRESSED THE ISSUE AND THE INVESTIGATION HAS BEEN COMPLETED. AGILENT TECHNOLOGIES HAS DETERMINED THE ROOT CAUSE AS SUCH; THE LOWER DOOR SUPPORT BRACKET, WHICH CONNECTS THE HINGES TO THE LOWER DOOR, IS ONLY ATTACHED TO THE PLEXIGLASS AND NOT TO THE METAL FRAME WHICH IS THE MAIN SUPPORT STRUCTURE OF THE LOWER DOOR. THE WEIGHT OF THE PLEXIGLASS DOOR IS IN TURN CRACKING/BREAKING AT THIS JOINT. CUSTOMERS HAVE BEEN NOTIFIED OF THIS ISSUE VIA A CUSTOMER LETTER. AGILENT TECHNOLOGIES WORKED WITH THE MANUFACTURER TO RE-DESIGN THE SUPPORT BRACKET FOR THE LOWER DOOR HINGES, SO THE WEIGHT OF THE LOWER DOOR ASSEMBLY IS NOT SUPPORTED BY THE PLEXIGLASS, BUT BY THE METAL FRAME OF THE LOWER DOOR. THIS NEW BRACKET IS BEING VERIFIED FOR EFFECTIVENESS; ONCE COMPLETED THIS BRACKET WILL BE INSTALLED AT THE CUSTOMER'S NEXT SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION THAT RECALL NUMBER, Z-1919-2024, HAS BEEN RECEIVED. AGILENT TECHNOLOGIES INITIATED A RECALL APRIL 2024 WITH THE SCOPE OF NOTIFYING ALL COVERSTAINER CUSTOMERS OF THE FOLLOWING ISSUE: THE LOWER DOOR THAT OPENS TO THE REAGENT BOTTLES IS CRACKING AND/OR BREAKING OFF IN THE UPPER CORNER OF THE PLEXIGLASS; RECALL EVENT ID (B)(4). CAPA01211 HAS ADDRESSED THE ISSUE AND THE INVESTIGATION HAS BEEN COMPLETED. AGILENT TECHNOLOGIES HAS DETERMINED THE ROOT CAUSE AS SUCH; THE LOWER DOOR SUPPORT BRACKET, WHICH CONNECTS THE HINGES TO THE LOWER DOOR, IS ONLY ATTACHED TO THE PLEXIGLASS AND NOT TO THE METAL FRAME WHICH IS THE MAIN SUPPORT STRUCTURE OF THE LOWER DOOR. THE WEIGHT OF THE PLEXIGLASS DOOR IS IN TURN CRACKING/BREAKING AT THIS JOINT. CUSTOMERS HAVE BEEN NOTIFIED OF THIS ISSUE VIA A CUSTOMER LETTER. AGILENT TECHNOLOGIES WORKED WITH THE MANUFACTURER TO RE-DESIGN THE SUPPORT BRACKET FOR THE LOWER DOOR HINGES, SO THE WEIGHT OF THE LOWER DOOR ASSEMBLY IS NOT SUPPORTED BY THE PLEXIGLASS, BUT BY THE METAL FRAME OF THE LOWER DOOR. THIS NEW BRACKET IS BEING VERIFIED FOR EFFECTIVENESS; ONCE COMPLETED THIS BRACKET WILL BE INSTALLED AT THE CUSTOMER'S NEXT SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    AGILENT TECHNOLOGIES HAS INITIATED A RECALL IN APRIL 2024 WITH THE SCOPE OF NOTIFYING ALL COVERSTAINER CUSTOMERS OF THE FOLLOWING ISSUE: THE LOWER DOOR THAT OPENS TO THE REAGENT BOTTLES IS CRACKING AND/OR BREAKING OFF IN THE UPPER CORNER OF THE PLEXIGLASS. CAPA01211 HAS ADDRESSED THE ISSUE AND THE INVESTIGATION HAS BEEN COMPLETED. AGILENT TECHNOLOGIES HAS DETERMINED THE ROOT CAUSE AS SUCH; THE LOWER DOOR SUPPORT BRACKET, WHICH CONNECTS THE HINGES TO THE LOWER DOOR, IS ONLY ATTACHED TO THE PLEXIGLASS AND NOT TO THE METAL FRAME WHICH IS THE MAIN SUPPORT STRUCTURE OF THE LOWER DOOR. THE WEIGHT OF THE PLEXIGLASS DOOR IS IN TURN CRACKING/BREAKING AT THIS JOINT. CUSTOMERS HAVE BEEN NOTIFIED OF THIS ISSUE VIA A CUSTOMER LETTER. AGILENT TECHNOLOGIES WORKED WITH THE MANUFACTURER TO RE-DESIGN THE SUPPORT BRACKET FOR THE LOWER DOOR HINGES, SO THE WEIGHT OF THE LOWER DOOR ASSEMBLY IS NOT SUPPORTED BY THE PLEXIGLASS, BUT BY THE METAL FRAME OF THE LOWER DOOR. THIS NEW BRACKET IS BEING VERIFIED FOR EFFECTIVENESS; ONCE COMPLETED THIS BRACKET WILL BE INSTALLED AT THE CUSTOMER'S NEXT SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    NO PATIENT HARM WAS INDICATED. A1-A6: PATIENT INFORMATION HAS NOT BEEN PROVIDED BY THE USER.

    Description of Event or Problem · 0

    THE UNITED KINGDOM CUSTOMER REPORTED THE LOWER DOOR OF THE INSTRUMENT BROKE IN THE TOP RIGHT-HAND CORNER AS IT WAS BEING CLOSED AND THE DOOR THEN FELL ON THE USER'S HAND AND IT WAS THOUGHT THE USER HAD A BROKEN FINGER OR FINGERS. THERE WAS NOTHING WRONG WITH THE DOOR PRIOR TO THIS; IT WASN'T STIFF, NO FORCE WAS REQUIRED TO OPEN THE DOOR, THERE WAS NO WEAR OR DAMAGE, AND NOTHING ELSE UNUSUAL WAS NOTICED ABOUT THE DOOR. THE AGILENT FIELD SERVICE ENGINEER (FSE) HAD SERVICED THE INSTRUMENT IN THE PAST WEEK AND ALSO FOUND NOTHING WRONG WITH THE DOOR. THE USER WENT TO THE ACCIDENT AND EMERGENCY ROOM AND X-RAYS FOUND THERE WERE NO BROKEN FINGERS. IT WAS NOTED THE FINGER WAS ABLE TO BE MANIPULATED BACK INTO ITS CORRECT ALIGNMENT AND THERE WILL BE SWELLING AND BRUISING BUT NOTHING MORE SERIOUS. THE FSE VISITED THE SITE FOR THIS COMPLAINT AND NOTED VISIBLE DAMAGE TO THE DOOR IN THE TOP RIGHT-HAND CORNER AND THE DOOR WOULD STRUGGLE TO BE OPENED AND WOULD NOT REMAIN OPEN AS IT WAS BROKEN AND DETACHED FROM THE SHOCK ABSORBERS AT THE TOP RIGHT-HAND CORNER. THE DOOR AND SHOCK ABSORBERS WERE REPLACED WHICH RESOLVED THIS MALFUNCTION. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. THE CUSTOMER WAS ABLE TO COMPLETE STAINING WITH ANOTHER INSTRUMENT. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640053 DAKO COVERSTAINER AUTOMATED SLIDE STAINER KPA AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. CS100 05700571112571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other