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

Catalog Number	60-01-04
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the cp5.A livanova field service went to customer site, ran the system and could not find an issue with the pump.Functional test passed positively and unit was returned to service.Initial serial read out (real time device parameters and setting recording file) of the pump was collected and no relevant info was stored.Second serial read out (real time device parameters and setting recording file) of the pump was collected and this was complete.The only error stored on the day of event indicates the signal from actual rotational speed is missing.However, no deviation was stored in the logs that could have cause the reported issue.According to information, no erc was used during this procedure with cp5.According to ifu, the cp5 must only be used for an optimized bypass in combination with air purge control (apc) and a tubing clamp (erc) with an additional bubble sensor.In this situation, if the "minimum rpm lockout" button is pressed, the flow can be dropped to zero in case of alarm.Through follow up with the customer, it was clarified the customer was not aware of the cp5 dropping flow when there is a pressure alert.From what customer stated, the reported yellow alert was where pressure alarm is located.The livanova field service was able to duplicate what had happened with the pressure simulator and test circuit.A device service history review has been performed and identified that the cp5 system was manufactured in 2023, while the s5 console was manufactured in june 2024 therefore recently installed at customer site.Based on all the information available, issue is most likely related to high pressure alarm and user pressing min lockout inadvertently made the flow drop to 0.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
Livanova received a report that a yellow icon showed up when customer tried to forward the flow, the cp5 had dropped the flow to 0 and there was no forward flow.Perfusionist cannot recall the information associated to the displayed alarm (yellow triangle alarm on cp5 panel).Through follow up, the perfusionist informed livanova the pump would not have forward flow for about 5-7 minutes.There is no report of any patient injury.

• Brand Name: CP5
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 20637895
• Report Number: 9611109-2024-00530
• Device Sequence Number: 7506423
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)230919
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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 Catalogue Number: 60-01-04
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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