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.
[67323115]
Patient information was not provided. 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 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
[67323116]
Sorin group (b)(4) received a report that the sorin s3 bubble detector alarmed randomly and the tubing size setting changed on its own during a procedure. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[86857757]
Livanova (b)(4) manufactures the s3 bubble detector. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). On january 24, 2017, a livanova field service representative was dispatched to the facility to investigate. The service representative was unable to reproduce the reported fault. The bubble sensor and bubble module were replaced as a precaution. The device was functionally tested without issue and was returned to service. These service results were inadvertently not included in the initial report, submitted february 13, 2017. If any additional information pertinent to the reported event is received, it will be submitted in a supplemental report. Evaluated on site by service rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611109-2017-00060 |
| MDR Report Key | 6326095 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-13 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-08-18 |
| Device Manufacturer Date | 2016-06-20 |
| 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 | 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 | 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 | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP DEUTSCHLAND |
| Manufacturer Address | LINDBERGHSTRASSE 25 MUNICH, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-13 |