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 16-02-85 manufactured by Livanova Deutschland Gmbh.
[183373985]
Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Through further follow-up communication with the chief perfusionist livanova learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry. This is not in alignment with current instruction for use however reportedly the devices are very clean and there is no sign of biofilm. The devices are located inside the operating theatre during use. We are currently waiting to know the result of microbial sampling performed at customer site. Reportedly the tests are still in progress. 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
[183373986]
A male patient born on (b)(6) undergone a cardiac surgery on (b)(6) 2019. The patient resulted to be infected with m. Avium intracellulare complex. This patient infection was previously reported under importer (b)(4) and manufacturer (b)(4). Following to additional information received from the hospital a patients mapping has been done and separated cases have been created.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2020-00187 |
| MDR Report Key | 9831339 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2017-05-02 |
| 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 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 | 16-02-85 |
| 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 |