MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-06 for SORIN S3 BUBBLE DETECTOR SENSOR 23-07-40 manufactured by Sorin Group Deutschland.
[61614277]
Patient information was not provided. Sorin group (b)(4) manufactures the sorin s3 bubble detector sensor. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). A sorin group field service representative was dispatched to the facility to investigate. The service representative confirmed the reported issue and replaced the bubble sensor. Subsequent testing did not identify further issues and the unit was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[61614278]
Sorin group (b)(4) received a report that an error message was displayed on the heart-lunch machine regarding the sorin s3 bubble detector sensor during a procedure. There is no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2016-00808 |
| MDR Report Key | 6149886 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-06 |
| Date of Report | 2016-11-10 |
| Date of Event | 2016-11-10 |
| Date Mfgr Received | 2016-11-10 |
| Device Manufacturer Date | 2016-02-04 |
| Date Added to Maude | 2016-12-06 |
| 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 | SORIN GROUP 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 | SORIN S3 BUBBLE DETECTOR SENSOR |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2016-12-06 |
| Model Number | 23-07-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP DEUTSCHLAND |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH, 80939 GM 80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-06 |