MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX CS-5100; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number	CS-5100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the loose waste tubing could not be determined.A siemens customer service engineer inspected the analyzer and secured the waste tubing to the nipple with a tie wrap to prevent future occurrence.No systemic deficiency was identified.The user was wearing a lab coat and gloves, but was not wearing a face covering or eye protection at the time of the event.The cs-5100 instructions for use, chapter 1 - introduction, section 1.6.2.7 - connecting the rinse tank/waste tank/ca clean ii container, informs the user: connect the waste tank nipple and the waste outlet nipple (w) on the back of the main unit with the urethane tube provided (6×4).The section also warns the user: make sure to connect a waste tank before turning on the main unit power.Chapter 2 - safety information, section 2.2.1 - general information, warns the user: should the instrument malfunction, turn the main switch off immediately and unplug the power cable.Contact your local sysmex service representative.Chapter 2 - safety information, section 2.2.4 - avoidance of infection, warns the user: 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.If something should get in your eyes or an open wound, rinse thoroughly with water and then contact your doctor immediately.Chapter 2 - safety information, section 2.3 - risk of infection/warning/caution labels on the instrument, warns the user: 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 3.4.4 - turning on the power, warns the user: check if a rinse tank and/or waste tank is connected before turning on the main unit power.Chapter 6 - maintenance, section 6.5.3 - discarding waste fluids, instructs the user to "make sure that the tube is not broken" after removing the cap, draining the fluid from the waste container, and re-attaching the cap.Chapter 7 - troubleshooting, section 7.2 - when you suspect an error, instructs the user to do the following if fluid leaks from the instrument: turn off the power and wipe off leaked fluid.If fluid leakage persists after turning on the power, contact your local sysmex service representative.
Event or Problem Description
The user identified liquid on the floor near the analyzer waste drawer and opened the drawer to investigate.The analyzer waste tubing was disconnected from the waste jug connection nipple, causing a liquid spray.The user was sprayed in the face by the analyzer waste liquid and was prescribed with an hiv medication for 28 days.

• Brand Name: SYSMEX CS-5100
• Common Device Name: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer (Section G): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer Contact: william haste ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439459
• MDR Report Key: 17882272
• Report Number: 1000515253-2023-00007
• Device Sequence Number: 7695677
• Product Code: JPA
• UDI-Device Identifier: 04987562425426
• UDI-Public: (01)04987562425426(11)200205
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CS-5100
• Device Catalogue Number: BY990757
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female