MAUDE Adverse Event Report: CLINISYS INC. SUNQUEST BLOOD BANK

Model Number	11.0.2
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This constitutes a malfunction of the sim ovision_f driver associated with the blood bank medical device.The investigation has shown that the reported incident only occurs when sim receives an incomplete message due to a read timeout while receiving data from an instrument.In this specific scenario, the sim ovision_f driver received an incomplete message (completion record missing) when a read timed out after 30 seconds and delivered partial results to the lab system flagged with an error message of "timed out." results from sim that include an error message are not processed further by the lab system (the error may be logged on the lab system).When the instrument sent the next message to the still running sim ovision_f driver on a different patient, information held in memory from the incomplete message was combined with the new message and delivered to the lab system.In addition, it was found that the issue will occur with the following ortho vision instrument models that are using the ovision_f driver: ortho vision, ortho vision max, ortho vision swift, ortho optix reader.There have been no instances of harm to patients reported.Root cause: the sim ovision_f driver versions 1.00 to 1.09 have a design error that fails to appropriately handle residual memory issues when a timeout occurs, preventing the sim message from processing due to an incomplete transfer from the instrument.Clients using this software with the ovision_f driver were notified in the clinisys notification titled psn-25-01.The clinisys team has documented the issue in change request 348918 and the fix will be available upon client request.Note: our initial mdr submission, emailed on march 18, 2025, was not accepted because we were unable to use the legacy fda electronic submission gateway (esg) due to unresolved technical issues.The report was subsequently submitted as soon as feasible using the new esg system.
Event or Problem Description
Clinisys recently identified an issue involving blood bank with sunquest instrument manager (sim).The issue occurs when a laboratory instrument sends an incomplete message for a sample.This triggers a read timeout in our sim ovision_f driver after 30 seconds, resulting in a "timed out" error message for that initial sample.However, the driver can retain the partial data transfer in memory, leading to potential data merging with the subsequent sample's transmission.There have been no instances of harm to patients reported.

• Brand Name: SUNQUEST BLOOD BANK
• Common Device Name: BLOOD BANK
• Manufacturer (Section D): CLINISYS INC.; 3300 e. sunrise dr.; tucson AZ 85718
• Manufacturer (Section G): CLINISYS INC.; 3300 e. sunrise dr.; tucson AZ 85718
• Manufacturer Contact: steven bishop ; 3300 e sunrise dr; tucsom, AZ 85718 ; 5205702062
• MDR Report Key: 21861540
• Report Number: 2029302-2025-00001
• Device Sequence Number: 4695443
• Product Code: MMH
• UDI-Device Identifier: B236BB11020
• UDI-Public: +B236BB11020/$$711020014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK160005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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
• Patient Sex: Unknown