FDA Adverse Event
Other
Summary report: N
PLASMAPHERESIS SET
MDR report key: 1496807
·
Received October 6, 2009
Report
- Report Number
- 1219343-2009-00004
- Event Type
- Other
- Date Received
- October 6, 2009
- Date of Event
- September 2, 2009
- Report Date
- October 5, 2009
- Manufacturer
- HAEMONETICS CORP.
- Product Code
- KSB
- PMA / PMN Number
- BK020001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DONOR WAS SENT TO HOSPITAL FOR OBSERVATION, NO ILL EFFECT NOTED, DONOR IS FINE.
Description of Event or Problem · 1
DURING A PLASMAPHERESIS PROCEDURE, RED CELL SPILL WAS NOTED. PROCEDURE WAS DISCONTINUED. THE CENTER NOTICED A BROKEN SEAL IN THE COLLECTION BOWL. DONOR HAD NO REPORT OF PROBLEM, BUT WAS SENT TO HOSPITAL FOR EVAL OF POSSIBLE SMALL AIR EMBOLISM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMAPHERESIS SET | PLASMAPHERESIS SET | KSB | HAEMONETICS CORP. | 625B | 0908039B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Hospitalization |