MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-13 for HEATER-COOLER SYSTEM 3T 16-02-80 manufactured by Livanova Deutschland Gmbh.
[188707123]
There was no known patient involvement. The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402). Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova deutschland manufactures the heater-cooler system 3t. The incident occurred in ome, italy. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Livanova initiated an investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[188707124]
Livanova deutschland received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera. The lab report confirming the reported contamination has been provided to livanova. There is no known patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2020-00192 |
| MDR Report Key | 9831527 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2013-02-20 |
| Date Added to Maude | 2020-03-13 |
| 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 | LIVANOVA DEUTSCHLAND GMBH |
| Manufacturer Street | LINDBERGHSTR. 25 |
| Manufacturer City | MUNICH 80309 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 80309 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2076/2081-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEATER-COOLER SYSTEM 3T |
| Generic Name | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS |
| Product Code | DWC |
| Date Received | 2020-03-13 |
| Model Number | 16-02-80 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA DEUTSCHLAND GMBH |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH 80309 GM 80309 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |