D
Patient 1
PROCESS DISPOSABLE CRACKED DURING CENTRIFUGATION ALLOWING BLOOD TO LEAK INTO CENTRIFUGE WELL. BLOOD WAS CONTAINED WITHIN CENTRIFUGE CHAMBER. NO INJURY TO OPERATOR OR PT. INCIDENT DID NOT RESULT IN EXPOSURE AS DEFINED BY OSHA.
MAUDE MDR 456051
- MDR report key
- 456051
- Report number
- 1225520-2003-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-03-25
- Date received
- 2003-04-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JOHN BONASERA, DIRECTOR
- Address
- 40 GRISSOM RD SUITE 100 PLYMOUTH MA 02360 US
- Phone
- 508-508-5087
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SMARTPREP2 PC SYSTEM & APC-60 (ACCESSORY) | CENTRIFUGE BLOOD PROCESSING & ACCESSORY | HARVEST TECHNOLOGIES | JQC | SMP2-115 & APC-60 | SMP2-115 & APC-60 | UNK FOR ACCESSORY | N | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-04-22 | 0 | 1. O |