MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-03 for SORIN S3 BUBBLE DETECTOR 23-07-50 manufactured by Sorin Group Deutschland.
[46564646]
There was no report of patient injury. The device has not been returned to sorin group (b)(4). Sorin group (b)(4) manufactures the sorin s3 bubble detector. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the sorin s3 bubble detector intermittently gave a false alarm during a procedure. There was no report of patient injury. A sorin group field service representative was dispatched to the facility to investigate. The perfusionist informed the service representative that the bubble sensor was replaced with a spare, which rectified the issue. Visual inspection of the replaced sensor identified deflated bladders. A new bubble sensor was provided to the customer to replace the spare. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[46564647]
Sorin group (b)(4) received a report that the sorin s3 bubble detector intermittently gave a false alarm during a procedure. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[47817293]
The initial medwatch report for this event, filed on june 3, 2016, referenced an s3 bubble detector, when the involved device was an s5 bubble detector. Sorin group (b)(4) received a report that the sorin s5 bubble detector intermittently gave a false alarm during a procedure. There was no report of patient injury. Brand name: sorin s5 bubble detector. Pma/510k#: k071318. Sorin group (b)(4) manufactures the sorin s5 bubble detector. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the sorin s5 bubble detector intermittently gave a false alarm during a procedure. There was no report of patient injury. A sorin group field service representative was dispatched to the facility to investigate. The perfusionist informed the service representative that the bubble sensor was replaced with a spare, which rectified the issue. Visual inspection of the replaced sensor identified deflated bladders. A new bubble sensor was provided to the customer to replace the spare. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[48328837]
Sorin group (b)(4) manufactures the sorin s3 bubble detector. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the sorin s3 bubble detector intermittently gave a false alarm during a procedure. There was no report of patient injury. The reported issue was caused by a damaged bubble detector and could be resolved by replacing the faulty component. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Sorin group (b)(4) has initiated a root cause investigation (b)(4) for this type of issue. Evaluated on site by sorin service rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611109-2016-00315 |
| MDR Report Key | 5699466 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-03 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-06-03 |
| Device Manufacturer Date | 2000-10-02 |
| Date Added to Maude | 2016-06-03 |
| 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 S3 BUBBLE DETECTOR |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2016-06-03 |
| 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 | 2016-06-03 |