MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-18 for ERC 60-05-65 manufactured by Sorin Group Usa, Inc..
[52388621]
Patient Sequence No: 1, Text Type: N, H10
[52388622]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5885256 |
| MDR Report Key | 5885256 |
| Date Received | 2016-08-18 |
| Date of Report | 2016-08-12 |
| Date of Event | 2016-08-01 |
| Report Date | 2016-08-12 |
| Date Reported to FDA | 2016-08-12 |
| Date Reported to Mfgr | 2016-08-12 |
| Date Added to Maude | 2016-08-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERC |
| Generic Name | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS |
| Product Code | KRI |
| Date Received | 2016-08-18 |
| Catalog Number | 60-05-65 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP USA, INC. |
| Manufacturer Address | 14401 W. 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-18 |