MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND 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	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (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 livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative tested the device but was unable to reproduce the reported issue.The customer reported that the issue only occurred for a few days and then went away.They also reported that they have not returned the device to service.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that the flow rate was not displayed on the centrifugal pump system with tubing clamp during priming.There was no patient involvement.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• MDR Report Key: 6595971
• Report Number: 9611109-2017-00363
• Device Sequence Number: 16353272
• Product Code: DWA
• UDI-Device Identifier: 04033817900986
• UDI-Public: 010403381790098611160316
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/26/2017

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: 60-02-15
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1