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

Model Number	10-85-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the s5 double head pump.The incident occurred in concord, california.Livanova initiated an investigation.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 s5 double head pump gave a fault in motor controller error message (code 442) during procedure.There was no patient injury.
Additional Manufacturer Narrative
H 11:no evidence of service intervention is currently available.Complaints database analysis revealed no similar event since unit installation in 2019.Moreover, the complaints database analysis, pointed out that no concerning trend has been identified, thus excluding any manufacturing issues as per the s5 list of error codes and s5 service manual the error code 442 indicates that a discrepancy between the set value for the pump rpm and the actual value and the pump stops due to a high current consumption.This error code can be caused by: - occlusion set too hard; - wrong tubing; - rotor blocked by a foreign object; - a rotor tight rotating most likely due to defective bearing.No other specific action was currently deemed necessary, livanova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.
Event or Problem Description
See initial report.

• Brand Name: S5 DOUBLE HEAD 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
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19687681
• Report Number: 9611109-2024-00296
• Device Sequence Number: 12532868
• Product Code: DWB
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)190828
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2024

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: 10-85-00
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2019
• 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