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U.S. Department of Health and Human Services

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

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ONEBLOOD, INC. REGULATED SOFTWARE APPLICATION (RSA) BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES Back to Search Results
Model Number 1.0.32.1
Device Problem Nonstandard Device (1420)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2019
Event Type  Malfunction  
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 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.

 
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Brand NameREGULATED SOFTWARE APPLICATION (RSA)
Type of DeviceBLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
Manufacturer (Section D)
ONEBLOOD, INC.
3000 w cypress creek rd.
fort lauderdale FL 33309
Manufacturer Contact
jared mcdonley
3000 w cypress creek rd.
fort lauderdale, FL 33309
9543781794
MDR Report Key9517030
MDR Text Key219778898
Report Number1077496-2019-00003
Device Sequence Number1
Product Code MMH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberBK110048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation RISK MANAGER
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 12/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number1.0.32.1
Device Catalogue Number1.0.19.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/17/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/24/2019 Patient Sequence Number: 1
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