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	Decreased Pump Speed (1500)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received report that dashes were displayed in the rpm menu with/without rotating the speed knob of a s5 mast roller pump.Reportedly, the pump was not spinning when rotating the set knob.The issue occurred during priming.There was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).The motor controller board was suspected to be defective.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Through follow-up communication livanova learned that the distributor engineer troubleshooted the issue at the customer site without detecting deviations.The unit was found to be working according to specifications.In addition, it was learned that the issue occurred only once and the pump was put back in service after having been checked by the distributor engineer.No further issues occurred.The serial read-out of the involved pump (real time device parameters and setting recording file) was analyzed.Results confirmed the reported event.An error code was found to be stored in the pump micro-controller.Based on the investigation performed for similar cases, the most likely root causes of the identified error code are: - defective resolver located in the pump head - defective motor control board taking into account that no hardware malfunctions were detected during the checks performed by the distributor engineer on site, that no components were replaced and that the issue did not recur, it is reasonable to assess that the reported event was caused by a temporary loose connection between the resolver and the motor control board, re-established with the restart of the pump.

• 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: 14798694
• Report Number: 9611109-2022-00313
• Device Sequence Number: 20360381
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)210727
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062396
• 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): 06/22/2022

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: 10-88-00
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2021
• 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