MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-13 for SORIN S3 BUBBLE DETECTOR 23-07-50 manufactured by Sorin Group Deutschland.
[67333119]
Sorin group (b)(4) manufactures the sorin s3 bubble detector. 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 informed by the user was not able to clear the alarm via control panel so he decided to switch-off the bubble module to resolve the reported malfunction. A sorin group field service representative was dispatched to the facility to investigate. The user informed the service representative that the alarm could not be cleared via the control panel. The bubble module was switched off to correct the issue. The service representative confirmed the issue and replaced the defective bubble sensor. Functional control and a test run did not identify any further issues. A loan bubble module has been provided to the customer while an investigation is performed. 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
[67333120]
Sorin group (b)(4) received a report that the sorin s3 bubble detector caused a false alarm and it triggered a pump stop during a procedure. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2017-00069 |
| MDR Report Key | 6326117 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-01-19 |
| Device Manufacturer Date | 2016-10-10 |
| Date Added to Maude | 2017-02-13 |
| 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 | LINDBERGHSTRASSE 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 |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2017-02-13 |
| Model Number | 23-07-50 |
| 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 | LINDBERGHSTRASSE 25 MUNICH, 80939 GM 80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-13 |