MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP 150 (S5 RP150); CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-80-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that, during ser up after a few seconds that the pump module is running, a s5 roller pump 150 displayed error message pump motor control fault 1 on the display.Despite several attempts to reset the pump, the message remains.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump 150.The incident occurred in italy.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: a complaints database review has been performed and it was determined that this complaint is a duplicate of another one, already submitted (mfr #9611109-2024-00137, livanova ref.(b)(4)).Therefore, this event will be voided.
Event or Problem Description
See initial report.

• Brand Name: S5 ROLLER PUMP 150 (S5 RP150)
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18855679
• Report Number: 9611109-2024-00127
• Device Sequence Number: 18213456
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: 010403381790038211180322
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/07/2024

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: 10-80-00
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2018
• 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