MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	60-01-04
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.Evaluation and functional checks were performed; unit was found functional and ready for use.The serial read-out of the pump (real time device parameters and setting recording file) was extracted and analyzed: no error message was recorded at the time of the failure.The investigation is on-going.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 an unknown event, occurred at 10:57, triggered a negative pressure alarm on a centrifugal pump 5 (cp5); the maximum amount of flow achieved was 1.74 lpm with maxed out rpms of 3500.The issue occurred during procedure, during clamping.After two (2) minutes of low flow, and customer switched to hand cranking to allow more time to troubleshoot; no alerts or alarms was displayed.Then, the involved drive unit was replaced with a one belonging to a new pump by the customer.Full flow was re-established.The total time of low flow/hand cranking was approximately seven (7) minutes.There was no patient injury.
Additional Manufacturer Narrative
A livanova field service technician was dispatched to the facility but was not able to reproduce the issue.The unit was inspected: mechanical/electrical checks and functional tests were performed as per tsi and successfully passed therefore the unit was released back to its expected functions.The serial readout of the centrifugal pump has been pulled out and analyzed revealing that no technical errors were stored around the time of the event (10:57 am on august 22, 2023).Based on the service activity and considering the serial read-out analysis, a hardware malfunction of the livanova pump can be ruled out.However, it cannot be excluded that the inability to generate a proper flow could be caused by any monitoring function activated during the procedure with still alarm condition on (e.G.Pressure alarm).The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17921247
• Report Number: 9611109-2023-00520
• Device Sequence Number: 2956736
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)181008
• 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): 03/25/2024

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: 60-01-04
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown