MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	60-02-15
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sorin group (b)(4) manufactures the sorin centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The device was returned to sorin group (b)(4) for further investigation.Evaluation of the returned device confirmed the reported failure.Visual inspection identified a crack in the housing of the returned flow sensor.Sorin group (b)(4) determined the damaged sensor to be the cause of the reported issue.The root cause of the damage could not be determined.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.
Event or Problem Description
Sorin group (b)(4) received a report that the flow sensor of the sorin centrifugal pump system with tubing clamp failed intermittently during priming.There was no patient involvement.

• Brand Name: SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• MDR Report Key: 6075716
• Report Number: 9611109-2016-00780
• Device Sequence Number: 888513
• Product Code: DWA
• UDI-Device Identifier: 04033817900986
• UDI-Public: 010403381790098611151118
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-02-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1