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

Model Number	48-20-00
Medical Device Problem Codes	Pumping Stopped (1503); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Livanova deutschland manufactures the cp5 console.The incident occurred in colombia.Livanova initated 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 has received a report that, during a transfer of the patient from icu to diagnostic imaging room, the cp5 console shut down in three (3) opportunities.After this events, the battery test request appeared in the cdm.The biomedical department was in charge to do the test and they report that all test (3 in total) failed.The battery capacity was 2,1 ah.There is not report of any patient injury.
Additional Manufacturer Narrative
Through follow-up with the technician, it was confirmed that no battery test had passed and that the battery capacity was below 14.0 ah.Indeed, according to device service manual, this value should be greater than 14.0 ah otherwise the batteries must be replaced.The review of similar cases did not identify any other complaints on hlm devices manufactured in 2021, thus a systematic battery failure can be ruled out.The event is an isolated case.Based on the data collected, it is possible to confirm that the involved device correctly displayed the warning "battery test required", and the most likely root cause could be traced back to a deep discharge of the batteries as the battery capacity was below the acceptable limit, such as to require a replacement of the batteries.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Through follow up with the customer, livanova learned that the battery test was always had been performed when the warning in the cdm appeared each 120 days or before.The customer doesn´t store the value of the passed battery test passed and the value of the last failed test was 2,1 ah.Regarding the technical specifications, all batteries that not pass the battery test, for a low capacity, below 11.2 ah, needs to he change the batteries that have failed are the original batteries, that comes with the equipment.The equipment was installed in (b)(6) 2022.The message that was displayed was last battery test failed.
Event or Problem Description
See initial report.

• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16750551
• Report Number: 9611109-2023-00174
• Device Sequence Number: 8626915
• Product Code: DWA
• UDI-Device Identifier: 04033817903123
• UDI-Public: (01)04033817903123(11)210526
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2023

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
• Was Device Available for Evaluation?: Yes
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 08/29/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 07/10/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2021
• 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