N
Patient 1
(B)(4). THE DEVICE WAS REQUESTED BUT NOT YET RECEIVED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
MAUDE MDR 6296809
- MDR report key
- 6296809
- Report number
- 8010762-2017-00030
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-23
- Date received
- 2017-02-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 76437 RASTATT GM
- Phone
- 497-497-4972
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE | MAQUET CARDIOPULMONARY AG | DTM | VKMO 11000 | 701049279 | 92171756 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-02 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE CUSTOMER: "THERE WAS BLOOD LEAKAGE FROM THE TUBING OF THE SAMPLING MAINFOLD DURING PATIENT USE." (B)(4).