FDA Adverse Event
Death
Summary report: N
TERUMO SCD
MDR report key: 546564
·
Received September 20, 2004
Report
- Report Number
- 1118880-2004-00008
- Event Type
- Death
- Date Received
- September 20, 2004
- Date of Event
- August 21, 2004
- Report Date
- August 31, 2004
- Manufacturer
- TERUMO MEDICAL CORP
- Product Code
- FKX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE HOSP REPORTED THAT A PT RECEIVED AN AS-5 (OPTISOL) LEUKO-REDUCED (LR) RED BLOOD CELL (RBC) UNIT AND SUBSEQUENTLY EXPERIENCED A TOTAL SYSTEM SHUTDOWN CONSISTENT WITH SEPTIC SHOCK. THE PT EXPIRED THE NEXT DAY. A PUBLISHED NEWS REPORT QUOTES THE BLOOD CENTER PRESIDENT AS STATING, "...THE RECENT FATALITY APPARENTLY CAME FROM A DONOR CARRYING A RARE BACTERIUM." THE SUSPECTED ORGANISM HAS BEEN REPORTEDLY IDENTIFIED AS PANTOEA AGGLOMERANS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO SCD | STERILE CONNECTING DEVICE | FKX | TERUMO MEDICAL CORP | 312 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Death | STORAGE BAG,| 2) PDI ARM PREP SCRUB SOLUTION,| 1) PALL DOCKABLE LEUKOREDUCTION (LR) FILTER &| 3) TERUFLEX BLOOD BAG. |