MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE CS-2500; AUTOMATED BLOOD COAGULATION ANALYZER

Catalog Number	BV981798
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Swelling/ Edema (4577)
Date of Event	06/24/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(6) contacted sysmex america inc.(sai) on june 28th, 2024, with a report of a user in germany misinterpreting the activated partial thromboplastin time (aptt) coagulation curve generated by cs-2500 automated coagulation analyzer.Erroneous results were reported and incorrect treatment, heparin, was administered due to the erroneous results.The following data was provided for investigation: the analyzer did not give a numeric result value.Instead, the following error was generated: dh 0 - no coagulation.Despite the "no coagulation" error message, the user reviewed the coagulation curve and determined a clotting time based on the user's interpretation of the graph.The user reported an aptt result of 53 seconds.Additional information was provided indicating that two additional sample results were misinterpreted in the same manner with erroneous low aptt results reported and heparin administered in error.On 7/16/2024 additional information was provided by siemens that the patient had expired on (b)(6) 2024.The sysmex automated blood coagulation analyzer cs-2500 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2 % sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory.The cs-2500 instructions for use (ifu) chapter 2 - principles of operation, section 2.1 - system overview, cautions the user: "results should always be evaluated in conjunction with clinical and other laboratory findings." chapter 8 section 8.5.2 analysis data errors, explains "no coagulation" message - the coagulation reaction was not detectable, due to low fibrinogen concentration, an anticoagulant sample or a reagent problem.It directs the user to: "reanalyze and make a comprehensive judgment, taking sample and reagent, etc.Into consideration.Also, set a longer detection time and repeat the analysis." the root cause of the event has been determined to be user error due to misinterpretation of analyzer data output.This event is being reported due to unnecessary administration of heparin leading to complications that culminated in the patient's death.
Event or Problem Description
An operator misinterpreted the activated partial thromboplastin time coagulation curve generated by the analyzer.Erroneous results were reported.Patient received unnecessary heparin treatment and expired due to consequences of internal bleeding and other clinical signs and symptoms.

• Brand Name: CS-2500
• 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: 19827370
• Report Number: 1000515253-2024-00006
• Device Sequence Number: 15619600
• Product Code: JPA
• UDI-Device Identifier: 04987562433735
• UDI-Public: 0104987562433735
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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 Catalogue Number: BV981798
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2019
• 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: Death
• Patient Sex: Female