N
Patient 1
(B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
MAUDE MDR 6892902
- MDR report key
- 6892902
- Report number
- 3007697864-2017-00054
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-08-30
- Date received
- 2017-09-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
- Phone
- 224-224-2242
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MARS | APPARATUS, HEMOPERFUSION, SORBENT | BAXTER HEALTHCARE - ROSTOCK | FLD | NA | 800473 | 22819 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-09-25 | 0 |
Event Narratives#
D
Patient 1
THIS IS A REPORT OF A PATIENT WHO IS UNDERGOING A TREATMENT WITH A MARS MONITOR. AFTER TREATMENT IT WAS NOTICED THAT THERE WAS A LEAK FROM THE ALBUMIN INTAKE LINE. THE ISSUE WAS DUE TO THE ALBUMIN INTAKE LINE OF THE MARS KIT BEING ALMOST COMPLETELY SEPARATED FROM THE SYSTEM, WITHOUT ANY PRIOR MANIPULATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.