MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SENSOR MODULE LEVEL/BUBBLE; MONITOR AND/OR CONTROL, LEVEL SNESING, CARDIOPULMONARY BYPASS

Model Number 23-30-20

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

Patient Problem No Patient involvement (2648)

Event Date 01/07/2014

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that the sensor module level/bubble did not detect all the bubbles during set up.There was no pt involvement.

Manufacturer Narrative

There was no pt involvement.Sorin group (b)(4) manufactures the sensor module level/bubble.The incident occured in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up will be sent when the investigation is complete.

• Brand Name: SENSOR MODULE LEVEL/BUBBLE
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SNESING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghst 25; munich D 80 939; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghst 25; munich D 80 939; GM D 80939
• Manufacturer Contact: cheri voorhees, mgr ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3644516
• MDR Text Key: 4352861
• Report Number: 1718850-2014-00023
• Device Sequence Number: 1
• Product Code: DTW
• Combination Product (y/n): N
• PMA/PMN Number: K955152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-30-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2006
• 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