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

Model Number 23-30-20

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2014

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that the sensor module level/bubble alarmed and the pump stopped during a procedure.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sensor module level/bubble.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the sensor module level/bubble alarmed and the pump stopped during a procedure.There was no report of patient injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(6) manufactures the sensor module level/bubble.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the sensor module level/bubble alarmed and the pump stopped during a procedure.There was no report of patient injury.A sorin group representative went on site and was unable to reproduce the reported issue.The bubble sensor and arterial pump along with all connections were checked and no issues were discovered.Loan modules were installed and the replaced level/bubble display module, level/bubble sensor module and dc/dc module were sent to sorin group (b)(4) for further evaluation.The investigation performed by sorin group (b)(4) was also unable to duplicate the issue.A test run of 24 hours with various adjustments and different rotational speeds was performed and no deviations were found during this time.The system worked as specified and no report of recurrence has been received.A review of the dhr was unable to identify and concessions, deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor the market for trends related to this issue and if any are identified, corrections will be recommended.

• Brand Name: SENSOR MODULE LEVEL/BUBBLE
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 3878048
• MDR Text Key: 4595049
• Report Number: 1718850-2014-00165
• Device Sequence Number: 1
• Product Code: DTW
• 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,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• 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
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2001
• 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: 89 YR