MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for SMART PERFUSION PACK 046006101 manufactured by Livanova Usa, Inc.
[181160458]
Blood accumulation on floor below the heart lung machine disposables. After checking that all screw ports were tightly connected, i noticed blood coming from the housing for the temperature probe site on the oxygenator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9763679 |
| MDR Report Key | 9763679 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-13 |
| Report Date | 2020-01-30 |
| Date Reported to FDA | 2020-01-30 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Product Code | DTZ |
| Date Received | 2020-02-27 |
| Model Number | 046006101 |
| Lot Number | 1928800045 |
| Device Availability | Y |
| Device Age | 1 DA |
| 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 | 2020-02-27 |