REGULATED SOFTWARE APPLICATION (RSA) 1.0.20.0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for REGULATED SOFTWARE APPLICATION (RSA) 1.0.20.0 manufactured by Oneblood, Inc..

Event Text Entries

[60445693] The deficient code was introduced with the release of rsa v1. 0. 12. 0 on 05/22/2016. A complaint pertaining to this system issue was received on (b)(6) 2016. An initial risk assessment and investigation was performed and staff incorrectly classified this complaint to a peripheral device used with the software. Upon further review on 10/21/2016, it was identified that this complaint was incorrectly assessed and was reclassified as a malfunction. A capa has been initiated to further investigate the mishandling of this complaint. Additionally, a review has been conducted on all open complaints to ensure no other complaints have been similarly mishandled. Review of the application code responsible for the errant functionality found the design was missing necessary coding to create the particular deferral when triggered by the first level answer (direct answer to a parent question). This is a result of incorrect design methods for handling the two dhq records created during this process. No blood products or donors were affected as a result of the software design issue. A communication was provided to all users of the failure scenario. 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 10/26/2016. 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.
Patient Sequence No: 1, Text Type: N, H10


[60445694] On 10/21/2016, oneblood, inc. Identified that specific user circumstances could allow a potentially ineligible donor to be accepted despite answering "no" to donor history questionnaire (dhq) question #1: "are you feeling healthy and well today". When a donor answers an electronic dhq administered via a tablet computer, the dhq is submitted for review and follow up with the potential donor by a oneblood health history screener. After review with the donor, the dhq is submitted, the staff member will investigate the answer and not allow the donor to donate and the system applies any applicable deferrals based on dhq answers. For dhqs completed via a tablet, testing has confirmed that the intended one-day deferral that should be placed on the donor is not being applied resulting in a potentially ineligible donor to be accepted despite answering the dhq in a deferrable way. This failure scenario has been confirmed to only occur if the dhq response to question #1 is answered by the donor using a tablet. All other methods of dhq completion have been confirmed to not represent this risk. Additionally, the failure would only manifest if staff incorrectly allow progression of the donation after health screening or the donor attempts to donate again on the same day. Review of production data found that no inappropriate donations have occurred as a result of this potential failure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1077496-2016-00001
MDR Report Key6104457
Date Received2016-11-15
Date of Report2016-11-15
Date of Event2016-09-08
Date Mfgr Received2016-09-08
Device Manufacturer Date2016-05-22
Date Added to Maude2016-11-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MARLENE PAGAN
Manufacturer Street3000 W CYPRESS CREEK RD.
Manufacturer CityFORT LAUDERDALE FL 33309
Manufacturer CountryUS
Manufacturer Postal33309
Manufacturer Phone9547772591
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameREGULATED SOFTWARE APPLICATION (RSA)
Generic NameBLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
Product CodeMMH
Date Received2016-11-15
Model Number1.0.20.0
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerONEBLOOD, INC.
Manufacturer Address3000 W CYPRESS CREEK RD. FORT LAUDERDALE FL 33309 US 33309


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-11-15

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