MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN S3 BUBBLE DETECTOR; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number 23-07-50

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: SORIN S3 BUBBLE DETECTOR
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6290072
• MDR Text Key: 66173162
• Report Number: 9611109-2017-00016
• Device Sequence Number: 1
• Product Code: KRL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K955152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 23-07-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 62