MAUDE Adverse Event Report: ARC-ONE SOLUTIONS, LLC REGULATED SOFTWARE APPLICATION (RSA), VERSION 2.0; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number 2.0.1.0

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2019

Event Type  malfunction  

Event Description

Arc-one solutions received information regarding regulated software application (rsa), v2.0 noting potential miscalculation of storage records for products that went through the irradiation process be before midnight and finish after midnight.This rare scenario results in a miscalculation where "time taken out of storage" is interpreted by the software as a negative value causing a failure to trigger downstream effects such as application of a quarantine identification and prevention of unit distribution.Downstream effects have been confirmed to work again after an additional 24-hour time frame is passed, resulting in a positive "time taken out of storage" value.

Manufacturer Narrative

Regulated software application (rsa), v2.0 is used by a single corporate entity.This single entity was notified of the issue, workaround, and specifically impacted blood products on (b)(6) 2021.A query of all applicable blood product records identified 12 labeled as-3 red blood cells leukocytes reduced products that were out of storage for 34 minutes (4 minutes past the client defined specification) and shipped on (b)(6) 2019.Information of these units was provided to the client.The client has provided email notification that communication was received and are further evaluating these units for further action.To date, no reports of death or serious injury have been identified for this issue.A software fix is in progress.Details of completion and release will be provided in a supplemental report.

Manufacturer Narrative

A software modification was performed, verified, and validated.The scope of testing included the software modification itself, all potentially impacted areas of the software, and regression testing to ensure that the fix was effective and did not adversely affect the software.This software modification was released on 12/10/2021 as v2.0.2.1.While the software is ready for implementation, the sole user group was informed of the corrective version of the software being available.They requested delay until they are adequately prepared to install.As such, arc-one solutions will upload a follow-up report when the sole user group is running on the corrective version (v2.0.2.1).

Manufacturer Narrative

Currently, the becs is used only by a single corporate entity.On (b)(6) 2022, the patch version of the software was installed by our single client.As such, all users affected by the issue are currently working with the updated software application.

• Brand Name: REGULATED SOFTWARE APPLICATION (RSA), VERSION 2.0
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): ARC-ONE SOLUTIONS, LLC; 7901 riviera blvd; miramar FL 33023 6440
• Manufacturer Contact: jared mcdonley ; 7901 riviera blvd; miramar, FL 33023 ; 5616939183
• MDR Report Key: 12901067
• MDR Text Key: 282823647
• Report Number: 3016690356-2021-00001
• Device Sequence Number: 1
• Product Code: MMH
• UDI-Device Identifier: 0860006793708
• UDI-Public: (01)0860006793708(11)210505(10)2010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK200512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.0.1.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1