FDA Adverse Event
Death
Summary report: N
PALL LEUKOTRAP-SC RC
MDR report key: 547857
·
Received October 8, 2004
Report
- Report Number
- 9617787-2004-00001
- Event Type
- Death
- Date Received
- October 8, 2004
- Date of Event
- August 21, 2004
- Report Date
- September 1, 2004
- Manufacturer
- ENSATEC, S.A. DE C.V.
- Product Code
- CAK
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A PT DEATH OCCURRED DUE TO SEPTIC SHOCK THE DAY AFTER A TRANSFUSION OF A RED CELL UNIT STORED IN THE STORAGE BAG OF THE PALL FILTRATION SET. THE UNIT OF BLOOD WAS COLLECTED IN TERUMO COLLECTION SET IN 2004. THE RED CELL UNIT WAS TRANSFUSED IN 2004 AND THE PT DIED THE FOLLOWING DAY. THE STORAGE BAG AND CORRESPONDING SEGMENTS WERE CULTURED AND PANTOEA AGGLOMERANS WAS IDENTIFIED ON BOTH. BLOOD DONOR WAS ASYMPTOMATIC AT TIME OF DRAW AND A RECENT CULTURE (35 DAYS LATER) OF DONOR BLOOD SHOWED NO GROWTH OF THIS BACTERIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALL LEUKOTRAP-SC RC | LEUKOCYTE REDUCTION FILTRATION SYSTEM FOR RED BLOOD CELLS | CAK | ENSATEC, S.A. DE C.V. | 430-41 | 0450439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Death |