MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-31 for SORIN S3 BUBBLE DETECTOR 23-07-50 manufactured by Sorin Group Deutschland.
[66173162]
Patient identifier was not provided. Sorin group (b)(4) manufactures the sorin s3 bubble detector. This incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). A sorin group field service representative was dispatched to the facility to investigate. The service representative was informed by the user that the system was set to provide pulsatile flow. This flow control method is used in order to simulate the aortic and the mitral valve function but at the same time the peristaltic oscillation can trigger a bubble alarm if the tubing is not perfectly stabilized between the transceiver and the receiver of the signal in the bubble sensor. The user mistook the configuration of the tubing-clamp inserts and did not use all the proper inserts necessary to keep the tube stable while the bubble sensor was closed. The fluctuation of the flow in the inadequately-locked tubing lead to the reported issue. Functional testing of the device found it to be functioning according to specification. The service representative performed serial readouts of the arterial pump and bubble sensor module, which were sent to sorin group deutschland for analysis, and the unit was returned to service. Review of the readout data did not identify any deviations or non-conformities relevant to the reported issue. 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 on-site by sorin service rep.
Patient Sequence No: 1, Text Type: N, H10
[66173163]
Sorin group (b)(4) received a report that the sorin s3 bubble detector erroneously detected the presence of air in the tubing and alarmed, triggering a pump stop during a procedure. The alarm could not be cleared without resetting the pump. The pump was hand cranked for a few seconds while the arterial pump was reset, and the procedure continued without further incident. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2017-00016 |
| MDR Report Key | 6290072 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-31 |
| Date of Event | 2017-01-03 |
| Date Mfgr Received | 2017-01-03 |
| Device Manufacturer Date | 2014-01-27 |
| Date Added to Maude | 2017-01-31 |
| 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 BUBBLE DETECTOR |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2017-01-31 |
| Model Number | 23-07-50 |
| Device Availability | N |
| 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 | 2017-01-31 |