MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-27 for SORIN S5 BUBBLE DETECTOR FOR 3/8 TUBING 23-07-50 manufactured by Sorin Group Deutschland.
[55785464]
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 was found to have deflated cushions. This issue was discovered by a sorin group field service representative during service. There was no patient involvement. The service representative replaced the bubble sensor and performed a functional check and trial run. No further issues were discovered. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[55785465]
Sorin group (b)(4) received a report that the sorin s5 bubble detector was found to have deflated cushions. This issue was discovered by a sorin group field service representative during service. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2016-00678 |
| MDR Report Key | 5982188 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-27 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-10-15 |
| Device Manufacturer Date | 2010-01-21 |
| Date Added to Maude | 2016-09-27 |
| 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 | 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 FOR 3/8 TUBING |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2016-09-27 |
| 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 | LINDBERGHSTR. 25 MUNICH, 80939 GM 80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-27 |