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

Model Number	1.0.32.1
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A software database change was performed to deactivate the editing of all pooled plasma products and further prevent this scenario from occurring.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 database modification was implemented on 12/05/2019.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 issues are currently working with the updated software application.
Event or Problem Description
On 12/04/2019, oneblood became aware that under rare circumstances, rsa applies an incorrect expiration date to liquid pooled plasma products.This anomaly only applies the incorrect 1-year expiration date to liquid pooled plasma products if the product was originally manufactured as an 8 or 24-hour frozen pooled plasma product, which is then edited to a liquid pooled plasma product.Under this rare situation, the system would determine the expiration date based on the individual pooled plasma product expiration date instead of the final pooled plasma product expiration date.However, when a liquid pooled plasma product is originally manufactured and labeled without editing the correct 26 day expiration date is applied and printed on the product label.1 unit was found to be affected and labeled with the incorrect expiration date; as a result, 3 product bags were shipped but successfully returned.No unsuitable products were transfused to patients.On 12/05/2019, a software database change was performed to deactivate the editing of all pooled plasma products to prevent this scenario from reoccurring.Additionally, the user group was advised of the issue and the disablement of the errant functionality.This mdr is being filed because an inadvertent collection of these units could potentially result in adverse event(s) if not identified and corrected prior to the corrections made.The deficient code was introduced in software version (b)(4), released on 07/11/2017.

• 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: 9517030
• Report Number: 1077496-2019-00003
• Device Sequence Number: 14181228
• Product Code: MMH
• UDI-Device Identifier: 00860664000309
• UDI-Public: (01)00860664000309(11)191120(10)10321
• 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): 12/24/2019

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: 1.0.32.1
• Device Catalogue Number: 1.0.19.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/24/2019
• 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