FDA Adverse Event
Malfunction
Summary report: N
DEFENSE BLOOD STANDARD SYSTEM
MDR report key: 837594
·
Received February 23, 2007
Report
- Report Number
- 1119523-2007-00001
- Event Type
- Malfunction
- Date Received
- February 23, 2007
- Date of Event
- December 21, 2006
- Report Date
- February 22, 2007
- Manufacturer
- DOD/DBSS/PROJECT OFFICE
- Product Code
- MMH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DBSS, UNDER CERTAIN CONDITIONS DOES NOT CALCULATE THE EXPIRATION DATE OF CONVERTED PRODUCTS CORRECTLY. NO FACILITY HAS REPORTED ISSUING OR TRANSFUSING ANY EXPIRED PRODUCTS DUE TO THE SOFTWARE ANOMALY. DBSS TECHNICAL BULLETIN (DTB) 06-12 WAS ISSUED TO ALERT USERS OF TWO KNOWN SCENARIOS WHERE DBSS WILL INCORRECTLY CALCULATE THE EXPIRATION DATE WHEN CONVERTING PRODUCTS. ATTACHMENT: DTB 06-12.
Description of Event or Problem · 1
DBSS EXTENDED THE EXPIRATION DATE OF AN IRRADIATED PLATELET PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEFENSE BLOOD STANDARD SYSTEM | BLOOD ESTABLISHMENT COMPUTER SOFTWARE | MMH | DOD/DBSS/PROJECT OFFICE | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |