MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for LIVA NOVA SORIN 6F INSPIRE OXYGENATOR REF # 044003200 manufactured by Liva Nova Sorin / Liva Nova Usa, Inc..
[182922312]
Fluid was seen leaking out of the sorin inspire 6f oxygenator temperature port during priming. It was changed out and reported to the company. Thankfully it was noticed before cpb was initiated. Recently, among a discussion with colleagues this is a common serious problem (12+ cases at least) and blood leaks out of the port during the cpb run and a serious sterility and cross contamination issue as the temp probe is reused and put into the temperature prob port with the leak. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093618 |
| MDR Report Key | 9805331 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-08-08 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | LIVA NOVA SORIN 6F INSPIRE OXYGENATOR |
| Generic Name | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Product Code | DTZ |
| Date Received | 2020-03-06 |
| Model Number | REF # 044003200 |
| Lot Number | 1912700021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVA NOVA SORIN / LIVA NOVA USA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |