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

Model Number	CS-5100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cs-5100 instructions for use (ifu) chapter 3- principles of operation describes assessment flags that are displayed with analysis results.An asterisk [*] means that the result is of low-reliability.The [***.*] symbol means analysis results could not be obtained due to errors and other problems.All analyses generated assessment flags indicating errors occurred or low-reliability of results."no coagulation" and "slight coagulation" errors were generated.Chapter 7 - troubleshooting, displays the various producible errors, and the meanings associated with the errors.The probable cause for the "no coagulation" error indicates the coagulation reaction was not detectable, due to low fibrinogen concentration, an anticoagulant sample or reagent problem.To resolve the error, the user is to repeat the analysis and make an overall judgement of the sample and reagents.The probable cause for the "slight coagulation" error indicates the detected coagulation reaction was extremely weak, due to a sample with low fibrinogen concentration or due to a problem with the sample or reagent.To resolve the error, the user is to check the volume of the sample and reagent then repeat the analysis.For fibrinogen analysis, change the dilution ratio of the sample before repeating.Further verification of results is recommend prior to result reporting.The cs-5100 application sheet for fibrinogen with dade thrombin reagent: limitations of the procedure, provides the threshold concentration of interfering substances.Bilirubin concentrations up to 6 mg/dl will not interfere with the assay.The patient's bilirubin concentration was reported to be approximately 50 mg/dl, which exceeds the interfering substance threshold concentration.No product deficiency was identified.
Event or Problem Description
The patient received unnecessary cryoprecipitate and fresh frozen plasma transfusions due to flagged fibrinogen (fbg) results that were incorrectly reported to the medical team.Multiple samples from one patient were analyzed for fbg over the course of five days.The analyzer generated "no coagulation" and "slight coagulation" errors.The results were displayed with asterisks [*] or as suppressed results [***.*].The operator reported fbg < 50 mg/dl.The physician administered cryoprecipitate 14 times and fresh frozen plasma 6 times.The correct fbg values are unknown.It is unknown if corrected reports were issued.No harm was reported due to the unnecessary transfusions.

• Brand Name: 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
• MDR Report Key: 10477540
• Report Number: 1000515253-2020-00025
• Device Sequence Number: 14203578
• Product Code: JPA
• UDI-Device Identifier: 04987562425426
• UDI-Public: (01)04987562425426(11)190130
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: 08/21/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other