MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-16 for SORIN S5 BUBBLE DETECTOR 23-07-50 manufactured by Livanova Deutschland.
[60084272]
There was no patient involvement. The serial number of the bubble sensor is unknown, and the unique identifier (udi) number could not be determined. This information will be provided in a follow-up report if and when made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a follow-up report if and when made available. 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). A sorin group field service representative spoke with the customer and provided the bubble sensor part numbers. The customer plans to order new sensor(s) and install them on their own. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[60084273]
Sorin group (b)(4) received a report that the sorin s5 bubble detector was found to be defective during priming. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2016-00757 |
| MDR Report Key | 6108192 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-16 |
| Date of Report | 2018-01-06 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2017-12-15 |
| Date Added to Maude | 2016-11-16 |
| 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 | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2016-11-16 |
| Model Number | 23-07-50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA DEUTSCHLAND |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH 80939 GM 80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-16 |