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	12/16/2016
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).A sorin group field service representative was dispatched to the facility to investigate.The service representative was able to reproduce the reported issue and confirmed that the problem was caused by a loose guide sleeve in the scp centrifugal pump control panel.The loose guide sleeve was tightened to specification and a subsequent functional verification test was completed without further issue.The device was returned to service.The investigation is on-going.A follow-up report will be sent when the investigation is complete.
Event or Problem Description
Sorin group (b)(4) received a report that the speed adjustment encoder of the sorin centrifugal pump system with tubing clamp did not function properly post-procedure.There was no report of patient injury.

• 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: 6244562
• Report Number: 9611109-2016-00985
• Device Sequence Number: 650969
• Product Code: DWA
• UDI-Device Identifier: 04033817900986
• UDI-Public: 010403381790098611151005
• 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): 12/16/2016

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2016
• Initial Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1