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

Model Number	10-88-60
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/09/2017
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).Livanova (b)(4) requested the claimed pump for a dedicated investigation.An analysis of the pump serial read-out was performed and the reported failure could be confirmed.A defective resolver was determined as the cause of the reported issue.The complete pump head was replaced and the issue solved.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
Event or Problem Description
Livanova (b)(4) received a report that right after the power of the control panel of a s5 mast roller pump was turned on, the unit did not operate and an error message was displayed.This issue was identified by a livanova field service representative during maintenance.There was no patient involvement.

• Brand Name: S5 MAST ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• MDR Report Key: 9178236
• Report Number: 9611109-2019-00805
• Device Sequence Number: 3884815
• Product Code: DWB
• UDI-Device Identifier: 04033817900481
• UDI-Public: 010403381790048111170113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 10-88-60
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2017
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1