MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-24 for S3 LOW LEVEL II SENSOR 23-27-40 manufactured by Livanova Deutschland.
[75929463]
(b)(4) manufactures the s3 low level ii sensor. The incident occurred in (b)(6). This medwatch report is being filed on behalf of (b)(4). A (b)(4) field service representative was dispatched to the facility to investigate. The service representative tested the device and was unable to reproduce the reported malfunction. All functional tests conducted on each of the involved devices passed without issue. Visual inspection revealed the presence of dried blood in the level sensor. The user confirmed the that blood was observed in the level sensor during the procedure. The service representative performed a download of the pumps readouts and took pictures of the level sensor for further investigation by (b)(4). Analysis of the photographs confirmed the presence of blood on the level sensor and the pump read-outs confirmed the reported pump stop triggered by the level sensor. (b)(4) concluded that the issue was caused by the penetration of blood between the level pad and the sensor, which can disturb communication and cause the reported issue. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[75929544]
(b)(4) received a report that the s3 low level ii sensor gave a false alarm during a procedure which triggered a pump stop. The user reported that there were no issues with the cardiotomy level. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2017-00377 |
| MDR Report Key | 6589841 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-24 |
| Date of Event | 2017-04-28 |
| Date Mfgr Received | 2017-04-28 |
| Device Manufacturer Date | 2012-11-20 |
| Date Added to Maude | 2017-05-24 |
| 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 CO 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 | 2017-05-24 |
| Model Number | 23-27-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-05-24 |