MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-07-28 for S3 LOW LEVEL II SENSOR 23-40-20 manufactured by Livanova Deutschland.
[81324719]
Patient identifier was not provided. Livanova (b)(4) manufactures the s3 low level ii sensor. The incident occurred in (b)(6). (b)(4). A livanova field service representative was dispatched to the facility to investigate. The service representative tested the device with the customer and they were unable to reproduce the reported issue. The sensor was replaced as a precaution and returned to livanova (b)(4) for further evaluation. During functional evaluation at livanova (b)(4), the technician connected the level sensor to the s5 test bench and turned the sensor on and off and the s5 was able to recognize the sensor. The level symbol was correctly displayed when the level was raised above or lowered below the level, and the system alarmed as expected upon a low level. An internal inspection did not identify any abnormalities or defects. A 12 hour test run was performed and was completed without issue. The reported fault could not be reproduced. As the issue could not be reproduced, a root cause was not identified. The device was scrapped due to old age. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. 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
[81324720]
Livanova (b)(4) received a report that the s3 low level ii sensor did not alarm when the blood level dropped below the set level during a procedure. Following the procedure, the user attempted to trigger an alarm using priming solution and the device was found to be working properly. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2017-00575 |
| MDR Report Key | 6750104 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-07-28 |
| Date of Report | 2017-07-28 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-06-29 |
| Device Manufacturer Date | 2004-07-12 |
| Date Added to Maude | 2017-07-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOAN CEASAR |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287260 |
| Manufacturer G1 | LIVANOVA DEUTSCHLAND |
| Manufacturer Street | LINDBERGHSTR. 25 |
| Manufacturer City | MUNICH 80939 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 80939 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S3 LOW LEVEL II SENSOR |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | DTW |
| Date Received | 2017-07-28 |
| Returned To Mfg | 2017-07-07 |
| Model Number | 23-40-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA DEUTSCHLAND |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH 80939 GM 80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-28 |