MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-88-00
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The device has been requested for return to livanova (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
Event or Problem Description
Livanova (b)(4) received a report that the s5 mast roller pump did not properly read the flow during setup.The display showed dashes instead of numbers.The customer tried unplugging the pump connector from the panel and plugging it back in, but the issue persisted.Swapped out the pump and was able to proceed with the surgery.There was no patient involvement.
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).A livanova service representative was dispatched to the facility to investigate.He could reproduce the issue and replaced the complete mast pump to solve the problem.Subsequent functional testing and electrical safety tests were passed without further problems.The unit was returned to service.The defective pump along with the panel was returned to livanova usa for a visual inspection.The investigator had observed a physical damage to the exterior cable connector which was caused by the transportation for the return of the defective device.It was subsequently sent to livanova (b)(4) for a detailed investigation.Upon functional testing, the investigator could trace back the claimed deviations to an internal damage to the pcb: the internal can connection con2 of the hms board was damaged.Visual inspection had also confirmed physical damage to the exterior of the cable connector.Defective connector con2 of the hms board is deemed to be the root cause of the reported issue.The review of the dhr did not identify any non-conformity related to the issue.

• Brand Name: S5 MAST ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 6757241
• Report Number: 9611109-2017-00590
• Device Sequence Number: 16529294
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)170126
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• 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,Followup
• Report Date (Section B): 01/05/2018

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: 10-88-00
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1