MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-08 for SORIN S3 BUBBLE DETECTOR 23-07-40 manufactured by Sorin Group Deutschland.
[46857875]
There was no patient involvement. Sorin group (b)(4) manufactures the sorin s5 system. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the sorin s3 bubble detector alarmed when no bubble was present. The sensor was exchanged but it did not resolve the issue. This issue occurred during priming, so there was no patient involvement. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[46857876]
Sorin group (b)(4) received a report that the sorin s3 bubble detector alarmed when no bubble was present. The sensor was exchanged but it did not resolve the issue. This issue occurred during priming, so there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[55241491]
Sorin group (b)(4) manufactures the sorin s5 system. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the sorin s3 bubble detector alarmed when no bubble was present. The sensor was exchanged but it did not resolve the issue. This issue occurred during priming, so there was no patient involvement. A sorin group field service representative was dispatched to the facility to investigate. The service representative performed a visual inspection and functional tests and was unable to confirm the reported issue. The service representative performed a technical safety inspection without fault and returned the unit to the customer. As a the issue was not reproduced, a root cause could not be determined and no corrective actions were identified. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Sorin group (b)(5) will continue to monitor for trends related to this type of issue. Evaluated by sorin group service rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611109-2016-00350 |
| MDR Report Key | 5707767 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-09 |
| Date of Event | 2016-05-09 |
| Date Mfgr Received | 2016-07-29 |
| Device Manufacturer Date | 2005-08-08 |
| Date Added to Maude | 2016-06-08 |
| 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 | CARRIE WOOD |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 3034676461 |
| Manufacturer G1 | SORIN GROUP DEUTSCHLAND |
| Manufacturer Street | SORIN GROUP DEUTSCHLAND |
| 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 |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2016-06-08 |
| Model Number | 23-07-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-06-08 |