N
Patient 1
MAUDE MDR 5885256
- MDR report key
- 5885256
- Report number
- 5885256
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-08-01
- Date received
- 2016-08-18
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ERC | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS | SORIN GROUP USA, INC. | KRI | 60-05-65 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-08-18 | 0 |
Event Narratives#
D
Patient 1
THE AUTOCLAMP ON PUMP M ENGAGED PART WAY WHILE ON CARDIOPULMONARY BYPASS. THE PERFUSIONIST WENT ON PUMP AND EVERYTHING LOOKED FINE. SHE LOWERED THE FLOW TO APPLY THE AORTIC CROSS CLAMP AND WHEN COMING BACK UP ON FLOW SHE WAS UNABLE TO ACHIEVE FULL FLOW, ~ 5 LPM. SHE WAS ONLY ABLE TO FLOW 2-2.5 LPM. THE AORTIC CROSS CLAMP WAS REMOVED AND THE PATIENT WAS SUCCESSFULLY WEANED FROM CARDIOPULMONARY BYPASS. AFTER TROUBLE SHOOTING, IT WAS FOUND THAT THE AUTOCLAMP WAS PARTLY ENGAGED AND THUS LIMITING FLOW. THE AUTOCLAMP WAS COMPLETELY DISENGAGED AND THE FLOW INCREASED. THE REST OF THE CASE PROCEEDED WITHOUT INCIDENT.