MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-07 for SORIN S5 BUBBLE DETECTOR 23-07-50 manufactured by Sorin Group Deutschland.
[56923328]
Sorin group (b)(4) manufactures the sorin centrifugal pump system. The incident occurred in (b)(4). 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 cushions were found to be deflated during a procedure. There was no report of patient injury. A sorin group field service representative was dispatched the facility to investigate. The service representative was unable to identify the issue on site. The bubble sensor was returned to sorin group (b)(4) for further investigation. The investigation is ongoing. A follow-up report will be sent when the investigation is complete. Evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10
[56923329]
Sorin group (b)(4) received a report that the sorin s5 bubble detector cushions were found to be deflated during a procedure. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[73368035]
Livanova (b)(4) manufactures the centrifugal pump system. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The bubble sensor was returned to livanova (b)(4) for evaluation. Detailed inspection identified a tear in the right side pillow and the gel had leaked out. The specific cause of the tear cannot be determined as it occurred during use by the customer. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. A trend of failing bubble sensors due to leaks in cushions has not been identified so far. However, capa (b)(4) was initiated to evaluate the lifetime of the bubble sensor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611109-2016-00632 |
| MDR Report Key | 6012744 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-07 |
| Date of Report | 2017-03-24 |
| Date of Event | 2016-09-07 |
| Date Mfgr Received | 2017-03-01 |
| Device Manufacturer Date | 2016-02-03 |
| Date Added to Maude | 2016-10-07 |
| 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 S5 BUBBLE DETECTOR |
| Generic Name | DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2016-10-07 |
| Returned To Mfg | 2016-09-19 |
| Model Number | 23-07-50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-10-07 |