MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN S3 BUBB DET SENSOR, LOW LEVEL II; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number 23-27-40

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient involvement (2648)

Event Date 03/13/2015

Event Type  Other  

Event Description

Sorin group received a report that during a routine preventative maintenance the level sensor was found to be inaccurate.There was no involvement.

Manufacturer Narrative

There was no pt involvement.Sorin group (b)(4) manufactures the s3 bubb det sensor, low level ii.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that during a routine preventative maintenance the level sensor was found to be inaccurate.There was no pt involvement.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s3 bubble sensor.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that during a routine preventative maintenance the level sensor was found to be inaccurate.It displays mid-range when no fluid is present.The sensor was not available for evaluation.The facility retained the unit and did not want any repairs or have the unit returned for investigation.The clinician was notified that if the sensor was to be used in the future, it would need to be repaired or replaced.No nonconformities were noted during manufacturing record review.The issue will be monitored for trends and if identified, corrections will be recommended.

• Brand Name: SORIN S3 BUBB DET SENSOR, LOW LEVEL II
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munchen D8093 9; GM D80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munchen D8093 9; GM D80939
• Manufacturer Contact: cheri voorhees, mgr, qual assr. ; 14401 w 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4687956
• MDR Text Key: 5677780
• Report Number: 9611109-2015-00101
• Device Sequence Number: 1
• Product Code: DTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-27-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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