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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 1.0.32.0
Device Problem Nonstandard Device (1420)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2019
Event Type  malfunction  
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 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.
 
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Brand Name
REGULATED SOFTWARE APPLICATION (RSA)
Type of Device
BLOOD 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 Key9488760
MDR Text Key220636972
Report Number1077496-2019-00002
Device Sequence Number1
Product Code MMH
UDI-Device Identifier00860664000309
UDI-Public(01)00860664000309(11)191117(10)10320
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK110048
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 12/11/2019
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
Device Operator No Information
Device Model Number1.0.32.0
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? No
Initial Date Manufacturer Received 11/18/2019
Initial Date FDA Received12/18/2019
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
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