MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-04 for SORIN S3 BUBB DET 23-07-50 manufactured by Sorin Group Deutschland.
[59224182]
Sorin group (b)(4) manufactures the sorin centrifugal pump system. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Replacement parts have been provided to the customer. The defective unit has been requested for return to sorin group (b)(4). A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[59224183]
Sorin group (b)(4) received a report that the sorin s3 bubble detector was found to be defective during priming. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2016-00736 |
| MDR Report Key | 6078809 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-04 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2016-10-17 |
| Device Manufacturer Date | 2014-03-10 |
| Date Added to Maude | 2016-11-04 |
| 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 | 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 BUBB DET |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2016-11-04 |
| 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 | 2016-11-04 |