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 Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 mast roller pump.The incident occurred in oldenburg, germany.It was communicated that probably water sprayed on the affected roller pump from the hose of a heater cooler device and then the reported error was displayed.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.No damage attributable to water ingress could be found and the pump was found to be working within specification and passed functional tests.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that a mast roller pump gave a motor control failure error message during priming and the pump could no longer be started.Afterwards the pump worked and the error did not recur.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H.10: the serial read out of the pump (real time device parameters and setting recording file) was gathered and analyzed.The reported motor control failure could be confirmed.Through a follow up, communication livanova received confirmation, that the reported error code appeared right after the water spilled on the pump.In addition, it has been discovered, that the water spillage had been caused by the user, who made a mistake and pulled off the water hose, during operation.Based on information reported by the customer, and based on service findings, water dropped on the pump, due an user error.Leading to motor control failure error message.Water did not damage the pump, and error did not recur.Device passed all functional tests.And returned back into service.Since no serious injury occurred.And being the reported error code solely caused by user error.The event has been re-assessed as not reportable.

• Brand Name: S5 MAST ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15013553
• Report Number: 9611109-2022-00337
• Device Sequence Number: 2316541
• Product Code: DWB
• UDI-Device Identifier: 04033817900481
• UDI-Public: (01)04033817900481(11)200707
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown