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

Model Number	60-02-50
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2017
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 review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.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 knob of the sorin centrifugal pump system with tubing clamp did not properly control the pump speed during a procedure.There was no report of patient injury.
Additional Manufacturer Narrative
(b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).A livanova service representative was contacted by the customer and was informed that the encoder of the control panel did not control the pump speed.The service representative walked the customer through tightening of the knob over the phone, following which; the customer noticed that there was a grinding feel to the encoder as it was being turned.A replacement control panel was sent to the customer and replaced by the customer.The customer subsequently reported that the unit works without any issue.The replaced device has not been returned for evaluation; therefore no root cause can be determined.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• 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: 6290076
• Report Number: 9611109-2017-00045
• Device Sequence Number: 11005078
• Product Code: DWA
• UDI-Device Identifier: 04033817900993
• UDI-Public: 010403381790099311150915
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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: 60-02-50
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1