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

Model Number CS-5100

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2020

Event Type  Injury  

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", "slight coagulation" and "defective sample volume" 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 volumes of 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 cause for the "defective sample volume" error is inappropriate volume.To resolve the error, the user is to check the reaction curve and follow judgement criteria for the institution.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 threshold concentration for the interfering substance.No product deficiency was identified.

Event Description

The patient received an unnecessary cryoprecipitate transfusion due to flagged fibrinogen (fbg) results that were incorrectly reported to the medical team.One patient sample was analyzed for fbg.The analyzer generated "no coagulation", "slight coagulation" and "defective sample volume" errors.The results were suppressed results [***.*].The operator reported fbg < 50 mg/dl.The physician administered cryoprecipitate.The correct fbg value is unknown.It is unknown if corrected reports were issued.No harm was reported due to the unnecessary transfusions.

• Brand Name: CS-5100
• Type of Device: 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: nancy gould ; 577 aptakisic rd; lincolnshire, il ; 5439678
• MDR Report Key: 10478328
• MDR Text Key: 210167503
• Report Number: 1000515253-2020-00027
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 04987562425426
• UDI-Public: (01)04987562425426(11)190130
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS-5100
• Device Catalogue Number: BY990757
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other