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	03/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 mast roller pump.The incident occurred in saitama, japan.A livanova field service representative was dispatched to the facility to investigate the device and it was discovered that the tube insert of the pump had been misaligned when the power was turned on when the error occurred.The same situation was reproduced by the technician and the internal motor controller error message appeared.Most likely the error occurred due to the tube insert being misaligned, which placed a load on the guide roller.No other problems were found with the pump, and it was resolved without replacement.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 mast roller pump gave a motor controller failure error message when the power was turned on at setup.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: a complaints database review was carried out and pointed out that no concerning trend has been identified, thus excluding any manufacturing issues.Based on the collected information, a hardware malfunction of the pump can be ruled out as a potential root cause for the reported issue, that can be traced back to the tube insert misalignment that was not identified by the user before the powering on of the machine, causing an overload 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
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19077499
• Report Number: 9611109-2024-00176
• Device Sequence Number: 6424552
• Product Code: DWB
• UDI-Device Identifier: 04033817900481
• UDI-Public: (01)04033817900481(11)160808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2016
• 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