MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for SMART PERFUSION PACK, INSPIRE 8FS manufactured by Livanova Usa, Inc..
[184855395]
The perfusionist opened up the tubing pack for a pump set up, and the arterial pressure line connecter at the oxygenator was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9877733 |
| MDR Report Key | 9877733 |
| Date Received | 2020-03-25 |
| Date of Report | 2019-08-20 |
| Date of Event | 2019-08-16 |
| Report Date | 2020-02-25 |
| Date Reported to FDA | 2020-02-25 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | SMART PERFUSION PACK, INSPIRE 8FS |
| Generic Name | TUBING, PUMP, CARDIOPULMONARY BYPASS |
| Product Code | DWE |
| Date Received | 2020-03-25 |
| Lot Number | 1916300046 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA USA, INC. |
| Manufacturer Address | 14401 WEST 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |