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	11/18/2019
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, 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 implemented on (b)(6) 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 issues are currently working with the updated software application.
Event or Problem Description
On (b)(6) 2019, oneblood became aware that under rare atypical noncompliant circumstances, rsa will not prevent a user from collecting blood from a donor with a hemoglobin (hgb) below the lower acceptable limit.The software anomaly in question takes place during the process of entering a donor's "physical exam" information, which includes data such as blood pressure, pulse, temperature, weight, height, and hgb.Rsa provides a way for users to enter a second hgb value if the first value provided was too low to meet donation eligibility requirements (as determined by software validation), and the user determines that a repeat test is appropriate based on blood center sop.In rare situations, the system validation is not applying a donor deferral automatically, which would prevent ineligible collection when a second, low, hgb value is entered and a donor height value is not.0 units were collected from donors who had hgb levels too low to meet eligibility criteria.However, 68 donor records were identified as having no automatic deferrals placed on them due to the above scenario; each of the 68 were discovered by staff at the proper time and the donation processes ceased.The donor information was given to the record review department, and proper deferrals were applied manually.Mdr is being filed as an inadvertent collection of these units could potentially result in adverse event(s) if not identified and corrected.The deficient code was introduced in software version 1.0.32.0, released on 11/17/2019.On (b)(6) 2019, oneblood became aware that under rare atypical noncompliant circumstances, rsa will not prevent a user from collecting blood from a donor with a hemoglobin (hgb) below the lower acceptable limit.The software anomaly in question takes place during the process of entering a donor's "physical exam" information, which includes data such as blood pressure, pulse, temperature, weight, height, and hgb.Rsa provides a way for users to enter a second hgb value if the first value provided was too low to meet donation eligibility requirements (as determined by software validation), and the user determines that a repeat test is appropriate based on blood center sop.In rare situations, the system validation is not applying a donor deferral automatically, which would prevent ineligible collection when a second, low, hgb value is entered and a donor height value is not.0 units were collected from donors who had hgb levels too low to meet eligibility criteria.However, 68 donor records were identified as having no automatic deferrals placed on them due to the above scenario; each of the 68 were discovered by staff at the proper time and the donation processes ceased.The donor information was given to the record review department, and proper deferrals were applied manually.Mdr is being filed as an inadvertent collection of these units could potentially result in adverse event(s) if not identified and corrected.The deficient code was introduced in software version 1.0.32.0, released on 11/17/2019.

• 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: 9488760
• Report Number: 1077496-2019-00002
• Device Sequence Number: 3655210
• 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): 12/11/2019

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: 11/18/2019
• 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