N
Patient 1
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
MAUDE MDR 9811291
- MDR report key
- 9811291
- Report number
- 1416980-2020-01304
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-10
- Date received
- 2020-03-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- 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 | FLOW COUPLER | FLOWMETER, BLOOD, CARDIOVASCULAR | BAXTER HEALTHCARE CORPORATION | DPW | NA | 515101300010 | SP19D12-1366274 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-10 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THE FLOWCOUPLER DISLODGED. THE EVENT WAS FURTHER DESCRIBED AS "THE SURGEON WAS TRYING TO CLOSE THE FLOWCOUPLER, IT CAME OFF OF THE BLACK HOLDER?. THE EVENT OCCURRED DURING AN UNSPECIFIED MEDICAL PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.