MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-13 for SORIN S5 BUBBLE DETECTOR 23-07-50 manufactured by Sorin Group Deutschland.
[57400604]
Sorin group (b)(4) manufactures the sorin s5 bubble detector. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the sorin s5 bubble detector gave an incorrect reading during a procedure. There was no report of patient injury. A replacement bubble sensor was provided to the customer for installation. Follow-up communication with the customer confirmed that the replacement resolved the reported issue and the unit is now functioning as expected. The replaced device has been requested for return to sorin group (b)(4) for investigation. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[57400605]
Sorin group (b)(4) received a report that the sorin s5 bubble detector gave an incorrect reading during a procedure. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[66178606]
During the complaint investigation, it was determined that this is not a reportable malfunction, as the functionality of the device is not affected. The initial report, submitted on (b)(6) 2016 can be voided. No further follow-ups will be filed for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611109-2016-00660 |
| MDR Report Key | 6029007 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-13 |
| Date of Report | 2017-01-31 |
| Date of Event | 2016-09-16 |
| Date Mfgr Received | 2016-09-16 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2016-10-13 |
| 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 | 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 S5 BUBBLE DETECTOR |
| Generic Name | BUBBLE SENSOR TUBING 3/8 SORIN S5 SYSTEM |
| Product Code | KRL |
| Date Received | 2016-10-13 |
| Model Number | 23-07-50 |
| 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 | 2016-10-13 |