MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-18 for S5 SENSOR MODULE FOR BUBBLE DETECTOR 23-45-20 manufactured by Sorin Group Deutschland.
[40729376]
Patient information was not provided. The serial number has not been provided by the facility. Device has not been returned to sorin group (b)(6). The serial number has not been provided, so the manufacturing date is unknown. Sorin group deutschland manufactures the level sensor of s5 system. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group(b)(6). Sorin group (b)(6) received a report the s5 sensor module for bubble detector of sorin s5 system was not recognized and the alarm sounded. Patient status has not been obtained from the facility. The investigation is ongoing. A follow-up will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[40729377]
Sorin group (b)(6) received a report the s5 sensor module for bubble detector of sorin s5 system was not recognized and the alarm sounded. Patient status has not been obtained from the facility.
Patient Sequence No: 1, Text Type: D, B5
[48520609]
Serial number: (b)(4). Device manufacturer date (mm/dd/yyyy): 01/29/2015. (b)(4): no consequence or impact to patient.
Patient Sequence No: 1, Text Type: N, H10
[66236531]
Sorin group (b)(4) manufactures the level sensor of s5 system. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). The device was returned to sorin group (b)(4) for investigation. The device was functionally tested by the technician. However, the reported error could not be reproduced and the unit worked as expected. A replacement has been provided to the customer as a precaution. No further issues have been reported. As the reported issue could not be reproduced, a root cause could not be determined and corrective actions were not identified. 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. Evaluated by sorin group (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611109-2016-00176 |
| MDR Report Key | 5511426 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-18 |
| Date of Report | 2017-02-01 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2017-01-20 |
| Date Added to Maude | 2016-03-18 |
| 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 | S5 SENSOR MODULE FOR BUBBLE DETECTOR |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2016-03-18 |
| Model Number | 23-45-20 |
| 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 | 2016-03-18 |