MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-05 for S5 SENSOR MODULE FOR BUBBLE DETECTOR 23-45-20 manufactured by Sorin Group Deutschland.
[41938514]
Patient information was not provided. The device has not been returned to sorin group (b)(4). Sorin group (b)(4) manufactures the s5 sensor module for 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 display module for the s5 sensor module for bubble detector switched from 3/8'' to 1/4'' during the procedure, causing the detection to be lossed. No alarm sounded. The sensor was switched out to complete the procedure. There was no report of patient injury. A sorin group field service representative visited the facility to investigate and was unable to reproduce the reported issue. A readout of the bubble sensor module and arterial pump was conducted and a new bubble sensor will be provided to the customer. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[41938515]
Sorin group (b)(4) received a report that the display module for the s5 sensor module for bubble detector switched from 3/8'' to 1/4'' during the procedure, causing the detection to be lossed. No alarm sounded. The sensor was switched out to complete the procedure. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[71130123]
Livanova (b)(4) manufactures the s5 sensor module for bubble detector. The incident occurred in (b)(6). This medwatch report is filed on behalf of livanova (b)(4). The bubble sensor was returned to livanova (b)(4) for evaluation. During visual inspection, a pressure trail was identified on one cushion. However, the bubble sensor was tested with several qa-s5 sensor modules and all measurements were found to be within tolerance. The reported issue could not be confirmed. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611109-2016-00194 |
| MDR Report Key | 5549344 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-05 |
| Date of Report | 2017-03-16 |
| Date of Event | 2016-03-15 |
| Date Mfgr Received | 2017-02-22 |
| Device Manufacturer Date | 2015-07-24 |
| Date Added to Maude | 2016-04-05 |
| 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 | S5 SENSOR MODULE FOR BUBBLE DETECTOR |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2016-04-05 |
| Returned To Mfg | 2016-08-09 |
| Model Number | 23-45-20 |
| 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 | 2016-04-05 |