MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SCP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	60-02-15
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a scp flow measurement on the panel is defective during a procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the scp.As per customer information, flow measurement is out after about 10 min.The defective circuit board for flow measurement has been replaced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H 11: review of complaints database did not reveal further similar issues since unit manufacturing in 2017, neither concerning trend has been identified.Based on the above, the root cause of the reported event has been traced to a defective flow sensor connection on cpu board.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, and power overloads/surges but also to variability of micro subcomponents.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.

• Brand Name: SCP
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20288913
• Report Number: 9611109-2024-00435
• Device Sequence Number: 7996386
• Product Code: DWA
• UDI-Device Identifier: 04033817900986
• UDI-Public: (01)04033817900986(11)170814
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011838
• 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): 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: 60-02-15
• Device Catalogue Number: PUMP CONTROL PANEL
• Was Device Available for Evaluation?: No
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2017
• 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