MAUDE Adverse Event Report: ONEBLOOD, INC. REGULATED SOFTWARE APPLICATION (RSA); BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number	1.0.32.0
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A software modification was performed, verified and validated.The scope of testing included the software modification itself, and all potentially impacted areas of the software, and other regression testing to ensure that the fix was effective and did not adversely affect the software.The software modification was implemented on 11/20/2019 as v1.0.32.1.Notification of the correction was provided subsequent to implementation.Currently, the becs is used only by a single corporate entity.As such, all users affected by the issue are currently working with the updated software application.
Event or Problem Description
Describe event: on (b)(6) 2019, oneblood became aware that under rare atypical noncompliant user circumstances, rsa will not prevent a user from further manufacturing a whole blood parent product after the parent product was discarded.This occurs when the user incorrectly selects the wrong product (wb parent) in sterile connection, and then discards the wb parent at the completion of the sterile connection process instead of the unsuitable child product.Similarly, the software is not preventing the users from carry out a sterile connection process on a product such as whole blood, while the product was already manufactured further into individual components.Therefore, in these rare situations, the system is not preventing the unsuitable child product from being labeled and shipped. 2 products were labeled and shipped but were successfully either recalled or discarded at the hospital.11 total products have been identified as affected under this scenario.5 of these products were discarded in house and never shipped.4 additional products were shipped but investigation into them determined the shipped product to be suitable and only represent an error in documentation.Mdr is being filed as an inadvertent release of these units could potentially result in adverse event(s) if not identified and corrected.The deficient code was introduced with the release of rsa v1.0.0.0 (9/1/2011) but the logic was a carryover from v0.1.0.0 (2006) predating the current applicable 510(k).The software was missing validation logic that would prevent a child product from going through further manufacturing after the parent product was discarded in the system by another process. .

• Brand Name: REGULATED SOFTWARE APPLICATION (RSA)
• Common Device Name: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): ONEBLOOD, INC.; 3000 w cypress creek rd.; fort lauderdale FL 33309
• MDR Report Key: 9488908
• Report Number: 1077496-2019-00001
• Device Sequence Number: 3655230
• Product Code: MMH
• UDI-Device Identifier: 00860664000309
• UDI-Public: (01)00860664000309(11)191117(10)10320
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK110048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

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: No Information
• Device Model Number: 1.0.32.0
• Device Catalogue Number: 1.0.19.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/18/2019
• 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