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

Catalog Number	10-80-00Z
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 device displayed e 431 (431 fault motor control pump) during installation.There is no report of any patient injury.
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device.A new s5 single roller pump 150 was installed subsequent functional verification testing was completed without further issues and the unit was returned to service.The motor control failure was sent back to arvada and a new one was shipped and i installed that one on the system.No read-outs is available.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: the affected part was returned to manufacturer for a detailed investigation.The investigator could reproduce the reported issue.In order to fix it, motor control board (hms) was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Involved board's direct current (dc/dc) converter has date code 2206.This issue has been addressed by livanova non-conformity ncr-mun-2022-0178, the root cause for the displayed error codes is the delayed start of the dc/dc converter ic10.The complaint malfunction can only occur during the start-up phase (booting phase, t1 test).Once the dc/dc converter has started and the t1 test was positive, the pump is working as intended.The investigation showed that only converters with date code 2206 are concerned.As for the above, since the issue is always detectable before use, the event has been reassessed as not reportable.
Event or Problem Description
See initial report.

• Brand Name: S5 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15770165
• Report Number: 9611109-2022-00575
• Device Sequence Number: 6620629
• Product Code: DWB
• UDI-Device Identifier: 04033817902713
• UDI-Public: 010403381790271311220915
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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 Catalogue Number: 10-80-00Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown