BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS-2500

    MDR report key: 18721145 · Received February 16, 2024

    Report

    Report Number
    1000515253-2024-00003
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    January 12, 2024
    Report Date
    February 16, 2024
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    JPA
    PMA / PMN Number
    K172286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SYSMEX CORPORATION JAPAN (S-CORP) REVIEWED THE EVENT AND PROVIDED THE FOLLOWING INVESTIGATION SUMMARY: ACCORDING TO THE SERVICE ENGINEER, THE WASTE TUBE DISCONNECTED AS A RESULT OF THE METAL CONNECTOR DETACHING FROM THE WASTE BOTTLE LID. PLEASE REFERENCE "EXAMPLE IMAGE OF METAL CONNECTOR-WASTE BOTTLE LID JOINT ". S-CORP REQUESTED THE ASSEMBLY CONTAINING THE SUSPECT METAL CONNECTOR, FLOAT SWITCH ASSEMBLY NO. 19 (PART NUMBER 963-2001-9), FOR INVESTIGATION TO ASSESS THE CONDITION OF THE SCREW THREAD OF THE NIPPLE AT THE JOINT BETWEEN THE METAL CONNECTOR AND THE LID OF THE WASTE BOTTLE. THE REQUESTED ASSEMBLY HAD, HOWEVER, ALREADY BEEN DISCARDED. FURTHER INVESTIGATION COULD NOT BE PERFORMED. ROOT CAUSE OF THE WASTE TUBE DISCONNECTING COULD NOT BE DETERMINED. PART REPLACEMENT AT THE CUSTOMER SITE RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    IN CHILE, THE OPERATOR OF AUTOMATED BLOOD COAGULATION ANALYZER CS-2500 REPORTED AN EXPOSURE OF THE ANALYZER WASTE LIQUID TO THE EYES THAT OCCURRED ON JANUARY 12, 2024. PER THE OPERATOR, THE DRAIN TUBING DISCONNECTED FROM THE WASTE CONTAINER DURING ROUTINE OPERATION AND THE LIQUID WASTE SPRAYED OUT OF THE END OF THE TUBING THAT WOULD CONNECT TO THE WASTE CONTAINER. THE OPERATOR REPORTED THE TUBING HAD PREVIOUSLY DISCONNECTED ON JANUARY 8, 2024, BUT WAS RE-ATTACHED UNDER GUIDANCE OF THE SIEMENS REGIONAL SERVICE CENTER (RSC). TWO OPERATORS WERE AFFECTED. THIS REPORT DOCUMENTS THE EVENT FOR OPERATOR B. PLEASE REFERENCE MFR REPORT # 1000515253-2024-00002 FOR THE DOCUMENTATION OF THE EVENT FOR OPERATOR A. AT THE TIME OF THE EVENT, THE OPERATOR'S PERSONAL PROTECTIVE EQUIPMENT CONSISTED OF GOWN AND GLOVES. GOGGLES OR GLASSES WERE NOT USED. WARNING STATEMENTS PRESENTED THROUGHOUT THE CS-2500 INSTRUCTIONS FOR USE CALL ATTENTION TO IMPORTANT SAFETY AND OPERATIONAL INFORMATION. NON-COMPLIANCE WITH THIS INFORMATION CAN COMPROMISE THE SAFE OPERATION OF THE ANALYZER. CHAPTER 2 - SAFETY INFORMATION, SECTION 2.1.3 - AVOIDING INFECTIONS, WARNS THE OPERATOR: RISK OF INFECTION WHEN PERFORMING ANY TASK ON THE INSTRUMENT, SUCH AS TESTING, MAINTENANCE, PREPARATION, OR POST PROCESSING, BE SURE TO WEAR ADEQUATE PERSONAL PROTECTIVE EQUIPMENT, SUCH AS PROTECTIVE GLOVES, A PROTECTIVE MASK, PROTECTIVE EYEWEAR, AND A LAB COAT. WASTE FLUID, PARTS WHICH HAVE COME INTO CONTACT WITH IT AND USED CUVETTES SHOULD NEVER BE TOUCHED WITH BARE HANDS. SHOULD YOU INADVERTENTLY COME IN CONTACT WITH POTENTIALLY INFECTIVE MATERIALS OR SURFACES, IMMEDIATELY RINSE SKIN THOROUGHLY WITH WATER, THEN FOLLOW YOUR LABORATORY'S PRESCRIBED CLEANING AND DECONTAMINATION PROCEDURES. TAKE APPROPRIATE CARE IN HANDLING SAMPLES AND DISCARDING USED CUVETTES. USE OF PROTECTIVE GLOVES IS STRONGLY RECOMMENDED WHEN OPERATING, MAINTAINING, SERVICING OR REPAIRING THE INSTRUMENT. AFTER COMPLETION OF WORK, WASH HANDS WITH DISINFECTANT. IF SOMETHING SHOULD GET IN YOUR EYES OR AN OPEN WOUND, RINSE THOROUGHLY WITH WATER AND THEN CONTACT YOUR DOCTOR IMMEDIATELY. BE SURE TO CONNECT THE INSTRUMENT'S DRAIN TUBING TO A WASTE TANK AT THE FACILITY OR OTHER DEDICATED WASTE TANK. IF CONNECTING THE TUBING TO A WASTE TANK AT THE FACILITY, USE A WASTE TANK WITH A NIPPLE TO WHICH THE DRAIN TUBING CAN BE ATTACHED OR A WASTE TANK WITH OTHER MEANS OF SECURING THE TUBING IN PLACE SO AS TO AVOID THE RISK OF WASTE FLUID SPILLAGE. IN ADDITION, EXERCISE CARE SO AS TO AVOID SUCH SPILLAGE, FOR EXAMPLE BY REGULARLY VERIFYING THAT THE TUBE REMAINS PROPERLY SECURED IN PLACE. TAKE APPROPRIATE CARE IN HANDLING WASTE FLUIDS. IF YOU GET THEM ON YOUR SKIN OR CLOTHES, WASH THEM OFF. DO NOT DISCARD WASTE FLUIDS DURING THE ANALYSIS OPERATION. HANDLE THE WASTE TANK AND ITS CONTENTS SUPPOSING THAT THEY ARE CONTAMINATED BY A PATHOGENIC ORGANISM. DO NOT HANDLE THE WASTE TANK WITHOUT WEARING PROPER PROTECTIVE EQUIPMENT. CHAPTER 3 - PRINCIPLES OF OPERATION, SECTION 3.4.3 - INSPECTING BEFORE TURNING POWER ON, INFORMS THE OPERATOR: BEFORE TURNING ON THE INSTRUMENT, CHECK THE FOLLOWING ITEMS: CHECK THE TUBING AND CORD CONNECTIONS. MAKE SURE THAT NO TUBES ARE DISCONNECTED OR KINKED, AND THAT THE POWER CORDS OF THE INSTRUMENT AND THE PNEUMATIC UNIT ARE SECURELY PLUGGED INTO THE AC OUTLET. SECTION 3.4.4 - TURNING ON THE POWER, INFORMS THE OPERATOR: CHECK IF A RINSE TANK AND/OR WASTE TANK IS CONNECTED BEFORE TURNING ON THE MAIN UNIT POWER. THE EVENT INVESTIGATION IS ONGOING AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 0

    IN CHILE, THE OPERATOR OF AUTOMATED BLOOD COAGULATION ANALYZER CS-2500 REPORTED AN EXPOSURE TO WASTE LIQUID FROM THE ANALYZER, RESULTING IN THE ADMINISTRATION OF PROPHYLACTIC TREATMENT CONSISTING OF ACRIP TENGA (ORAL 1 TABLET EVERY 24 HOURS FOR 4 DAYS) AND KAPH OPHTHALMIC SOLUTION (1 DROP EVERY 4 HOURS FOR 7 DAYS). OPHTHALMOLOGY TREATMENT (EYE ANESTHESIA) WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386365 CS-2500 AUTOMATED BLOOD COAGULATION ANALYZER JPA SYSMEX CORPORATION, I SQUARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other