D
Patient 1
THE INITIAL REPORT RECEIVED (B)(6) 2009 INDICATED THAT A HOLE WAS OBSERVED IN THE PLASMA BAG CLOSE TO THE VALVE AFTER CENTRIFUGATION. THIS COULD POSSIBLY RESULT IN A SAMPLE LOSS.
MAUDE MDR 1369388
- MDR report key
- 1369388
- Report number
- 2950374-2009-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-03-30
- Date received
- 2009-04-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JEFF BROWNING
- Address
- 2711 CITRUS RD RANCHO CORDOVA CA 95742 US
- Phone
- 916-916-9168
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AXP PROCESSING SET | THERMOGENESIS CORP. | OAO | 8-5101 | 8-5101 | 28204-0000-01 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-04-22 | 0 |
Event Narratives#
N
Patient 1
THE AXP PROCESSING BAG IS THE COMPONENT OF THE AXP PLATFORM UNIT AND ARE SINGLE USE. THE INFO RECEIVED FROM THE USER INDICATED THERE WAS A HOLE IN THE PLASMA BAG CLOSE TO THE VALVE AFTER CENTRIFUGATION. PRODUCT HAS BEEN RECEIVED AND IS UNDER INVESTIGATION. THIS TYPE OF OCCURRENCE POSES NO RISK TO PT OR CAREGIVER. NO ADVERSE EVENT HAS BEEN REPORTED FOR THIS OCCURRENCE. TO ENSURE COMPLIANCE TO THE FDA REPORTING REQUIREMENTS UNDER SECTION 21CF803. THERMOGENESIS HAS TAKEN A CONSERVATIVE APPROACH AND MADE THE DECISION TO SUBMIT THESE TYPES OF OCCURRENCES..