FDA Adverse Event
Summary report: N
DOUBLE COLLECTION UNIT
MDR report key: 11556
·
Received February 7, 1994
Report
- Report Number
- MW4000228
- Date Received
- February 7, 1994
- Report Date
- June 8, 1993
- Manufacturer
- PHARMACEUTICAL DIV. MILES, INC.
- Product Code
- KSR
- Report Source
- Voluntary report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A 5-YR-OLD CHILD WITH ACUTE LEUKEMIA RECEIVED RED BLOOD CELLS COLLECTED WITH A RC FILTER AND SEVERE HEMOLYSIS WAS NOTED IN THE SAMPLE KEPT PRE-TRANSFUSION AND HEMOGLOBINURIA IN THE CHILD POST-TRANSFUSION. THERE WAS NO ADVERSE CLINICAL OUTCOME IN THIS PT. THROUGHOUT THE REACTION THE CHILD DID FINE. THE REACTION WAS NOT NOTED UNTIL ABOUT 2 HRS AFTER THE RED CELLS WERE TRANSFUSED. THE CHILD HAS GONE HOME WITH ABSOLUTELY NO FURTHER DIFFICULTIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DOUBLE COLLECTION UNIT | KSR | PHARMACEUTICAL DIV. MILES, INC. | CA2C15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR |