MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-04-02 for SORINGROUP 029395000 manufactured by Sorin Group Usa.
[19190770]
Overpressure valve on heart/lung machine began leaking during bypass run. Suction line stopped momentarily to replace valve. Unk fluid loss during leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518155 |
| MDR Report Key | 2518155 |
| Report Source | 99 |
| Date Received | 2012-04-02 |
| Date of Report | 2012-03-30 |
| Date of Event | 2012-03-28 |
| Date Facility Aware | 2012-03-28 |
| Report Date | 2012-03-30 |
| Date Added to Maude | 2012-04-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SORINGROUP |
| Generic Name | VA RELIEF CHECK VAL |
| Product Code | JOD |
| Date Received | 2012-04-02 |
| Catalog Number | 029395000 |
| Lot Number | 1200300126 |
| Device Expiration Date | 2015-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP USA |
| Manufacturer Address | 14401 W 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-02 |