MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-30 for SORIN S3 BUBB DET SENSOR, LOW LEVEL II 23-07-50 N/A manufactured by Sorin Group Deutschland.
[27080250]
Sorin group (b)(4) manufactures the sorin s3 bubb det sensor, low level ii. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group received a report that an s5 bubble sensor was not detecting bubbles. 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
[27080251]
Sorin group received a report that an s5 bubble sensor was not detecting bubbles. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[55219241]
Sorin group (b)(4) manufactures the sorin s3 bubb det sensor, low level ii. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group received a report that an s5 bubble sensor was not detecting bubbles. There was no patient involvement. The bubble sensor was returned to sorin group (b)(4) for further investigation. Visual inspection did not identify any abnormalities or defects. Functional testing and a hardware analysis could not reproduce the reported issue. One measurement was found to be slightly out of tolerance during analysis, however this measurement is unrelated to the reported issue. The returned sensor was scrapped upon completion of the evaluation. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611109-2015-00386 |
| MDR Report Key | 5112571 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-30 |
| Date of Report | 2015-09-01 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2016-08-25 |
| Device Manufacturer Date | 2014-01-15 |
| Date Added to Maude | 2015-09-30 |
| 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 | MS. 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 BUBB DET SENSOR, LOW LEVEL II |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2015-09-30 |
| Model Number | 23-07-50 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP DEUTSCHLAND |
| Manufacturer Address | LINDBERGSTR. 25 MUNICH, 80939 GM 80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-30 |