MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CP5 CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	48-20-00
Medical Device Problem Code	Decreased Pump Speed (1500)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that during procedure speed of a cp5 console dropped to 1000 rpm, which is the minimum threshold with no alarm showing.Speed was then tried to be increased, however there was no response from the cp5 control panel.System was rebooted and the issue was still present.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the cp5 console.The incident occurred in houston, texas.Through follow-up communication livanova learned that pressure threshold was set to zero by the customer.Therefore, when the pressure went below zero it would start to ramp down the rpm and not alarm.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Additional information has been requested and it has been revealed that the cp5 acts as per expectation and no alarm was requested based on additional information confirmed by the field service engineer, the event has been re-evaluated as not reportable event as the device acts as expected.

• Brand Name: CP5 CONSOLE
• Common Device Name: CONTROL, PUMP SPEED, 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: 18281758
• Report Number: 9611109-2023-00624
• Device Sequence Number: 6189923
• Product Code: DWA
• UDI-Device Identifier: 04033817903123
• UDI-Public: (01)04033817903123(11)220331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112225
• 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): 01/04/2024

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: 48-20-00
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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