FDA Adverse Event
Other
Summary report: N
BLOOD BANK CONTROL SYSTEM (BBCS)
MDR report key: 97405
·
Received June 13, 1997
Report
- Report Number
- 3028885-1997-00001
- Event Type
- Other
- Date Received
- June 13, 1997
- Date of Event
- June 6, 1997
- Report Date
- June 12, 1997
- Manufacturer
- BLOOD BANK COMPUTER SYSTEMS, INC.
- Product Code
- MMH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHEN A USER DELETES A UNIT DETAIL CMV ANTIGEN RECORD, ACCESSING VIA DONOR NUMBER, THE SOFTWARE IS NOT UPDATING THE IMCMV FIELD IN THE INVENTORY MASTER DATA RECORDS (INVMAST) TO BLANKS FOR THE PRODUCTS OF THE UNIT. THIS WILL HAPPEN ONLY FOR THE DELETION OF UNIT LEVEL "CMV" ANTIGEN RECORDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLOOD BANK CONTROL SYSTEM (BBCS) | BLOOD BANK SOFTWARE | MMH | BLOOD BANK COMPUTER SYSTEMS, INC. | * | RELEASE 4.0/4.1/4.2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |