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 Problems False Alarm (1013); Pumping Stopped (1503)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin s3 bubble detector.The 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 informed by the user was not able to clear the alarm via control panel so he decided to switch-off the bubble module to resolve the reported malfunction.A sorin group field service representative was dispatched to the facility to investigate.The user informed the service representative that the alarm could not be cleared via the control panel.The bubble module was switched off to correct the issue.The service representative confirmed the issue and replaced the defective bubble sensor.Functional control and a test run did not identify any further issues.A loan bubble module has been provided to the customer while an investigation is performed.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the sorin s3 bubble detector caused a false alarm and it triggered a pump stop during a procedure.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; lindberghstrasse 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstrasse 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6326117
• MDR Text Key: 67333119
• Report Number: 9611109-2017-00069
• Device Sequence Number: 1
• Product Code: KRL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-07-50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2016
• 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