FDA Adverse Event
Death
Summary report: N
SCREENING CELLS TRIO
MDR report key: 467164
·
Received June 18, 2003
Report
- Report Number
- 1623424-2003-00002
- Event Type
- Death
- Date Received
- June 18, 2003
- Manufacturer
- GAMMA BIOLOGICALS, INC.
- Product Code
- KSZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT RECEIVED 6 UNITS OF PACKED RED BLOOD CELLS, TWO OF WHICH WERE E+. THE PATIENT'S DEATH OCCURRED APPROXIMATELY 18 HOURS AFTER THE TRANSFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREENING CELLS TRIO | REAGENT RED BLOOD CELLS | KSZ | GAMMA BIOLOGICALS, INC. | NA | 0415620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |