MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-12-23 for CARDIOPLEGIA HEAT EXCHANGER 050228J manufactured by Sorin Group Italia Srl.
| Report Number | 9680841-2019-00043 |
| MDR Report Key | 9510653 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-12-23 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2019-12-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ENRICO GRECO |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer G1 | SORIN GROUP ITALIA SRL |
| Manufacturer Street | STRADA STATALE 12 NORD, 86 |
| Manufacturer City | MIRANDOLA, MODENA 41037 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41037 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOPLEGIA HEAT EXCHANGER |
| Generic Name | SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM |
| Product Code | DTN |
| Date Received | 2019-12-23 |
| Catalog Number | 050228J |
| Lot Number | 1812130043 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA SRL |
| Manufacturer Address | STRADA STATALE 12 NORD, 86 MIRANDOLA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-23 |