D
Patient 1
A MAXIMUM TIME TO PREPARATION (MTP) HOLD WAS NOT APPLIED TO AN ORIGINAL APHERESIS PRODUCT WHEN THE "USE MFG PREP TIME" OPTION WAS ENABLED.
MAUDE MDR 2627095
- MDR report key
- 2627095
- Report number
- 2435501-2012-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-05-07
- Date received
- 2012-06-21
- 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
- MELINDA BRYANT
- Address
- 115 TREE ST. FLOWOOD MS 39232 US
- Phone
- 855-855-8558
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LIFETEC ELITE V1.0 | LIFETEC ELITE V1.0 | IT SYNERGISTICS, LLC. | MMH | NA | NA | NA | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-06-21 | 0 |
Event Narratives#
N
Patient 1
ALTHOUGH THE DATE OF THIS REPORT EXCEEDS THE 30-DAY REPORTING PERIOD FOR A MFR IN REFERENCE TO 803.50 SUBPART E, THE INITIAL EVAL OF THE ERROR WOULD NOT CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS IN RESPONSE TO THE INITIAL ERROR AND INVESTIGATION REPORTED BY THE BLOOD CONNECTION. CORRECTIVE ACTION: AN INVESTIGATION INTO THE MTP HOLD ROUTINE WAS COMPLETED BY IT SYNERGISTICS AND THE DEFECT WAS IDENTIFIED. A CORRECTION WAS NEEDED TO A SQL STORED PROCEDURE TO PREVENT THE ISSUE FROM RE-OCCURRING. THE SOFTWARE PATCH HAS BEEN TESTED SUCCESSFULLY INTERNALLY AND FOUND NO ERROR OR ANOMALIES DURING TESTING, AND SUBSEQUENTLY WAS RELEASED ON (B)(4) 2012 TO ALL FACILITIES.