MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for S5 ROLLER PUMP 10-80-00 manufactured by Livanova Deutschland Gmbh.
[174623124]
There was no patient involvement. Livanova (b)(4) manufactures the s5 roller pump. The incident occurred in (b)(4). 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
[174623125]
Livanova (b)(4) received a report of a s5 roller pump shutdown during priming. The pump was replaced with a backup device. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2020-00014 |
| MDR Report Key | 9577234 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2006-04-20 |
| Date Added to Maude | 2020-01-10 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S5 ROLLER PUMP |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Product Code | DWB |
| Date Received | 2020-01-10 |
| Model Number | 10-80-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA DEUTSCHLAND GMBH |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |