FDA Adverse Event
Malfunction
Summary report: N
HEMOCARE BLOOD BANK DATA MGT. SYS.
MDR report key: 403242
·
Received June 28, 2002
Report
- Report Number
- 2437251-2002-00001
- Event Type
- Malfunction
- Date Received
- June 28, 2002
- Report Date
- June 27, 2002
- Manufacturer
- HEMOCARE/MEDIWARE INFO. SYS. INC.
- Product Code
- MMH
- Removal / Correction Number
- 2437251-052902-001C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN 2002, A CUSTOMER COMPLAINT WAS INVESTIGATED INVOLVING THE UNIT ANTIGEN TEST ENTRY OF THE HEMOCARE BLOOD BANK DATA MANAGEMENT SYSTEM VER.5.2B(B). DURING THE INVESTIGATION, IT WAS FOUND THAT WHEN ENTERING GREATER THAN FIFTEEN UNITS IN UNIT ANTIGEN TEST ENTRY, A PREVIOUSLY ENTERED UNIT WITH OR WITHOUT TEST RESULTS, CAN BE OVERRIDDEN WITH A NEW UNIT NUMBER. IF THE ORIGINAL UNIT HAD UNRELEASED ANTIGEN TEST RESULTS, THESE RESULTS CAN BECOME ATTACHED TO THE NEW UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCARE BLOOD BANK DATA MGT. SYS. | BLOOD BANK INFORMATION SYSTEM | MMH | HEMOCARE/MEDIWARE INFO. SYS. INC. | VERSION 5.2B(B) | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |