MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH CP5 DRIVE UNIT (WITH CABLE); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	60-01-04
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the cp5 drive unit.The incident occurred in usa.As per follow up, the customer uses a competitot disposables with a the competitor adaptor plate on the scp drive unit.They were trying to ramp up from a low speed but they said the flow didn¿t increase.They are not requesting service on the s5.They believe it was a the competitor disposable issue that they use with the competito coupler attached to the cp5 drive unit.The chief perfusionist confirmed that they initiated cpb uneventfully.Flow was reduced per the surgeon and when they tried to increase flow again, they did not get the expected response.The surgeon commented about the possible presence of clot and directed the perfusionist to change the entire hlm and disposables circuit instead of trying to troubleshoot various possible issues.The perfusionist did not reduce the rpms to zero to rule out decoupling of the drive motor/competitor adapter plate/competitor pump head.They also did not attempt to hand crank.Livanova initiated 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 cardiopulmonary bypass, the pump stopped working.There was no circulation until a new bypass machine was hooked up and started.Accorind to information this took approximately 8-10 minutes and required medications, blood products and cardiac massage.Staff from perfusion identified the tubing as a possible cause of malfunction.There is no report of any patient injury.

• Brand Name: CP5 DRIVE UNIT (WITH CABLE)
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• MDR Report Key: 18092429
• Report Number: 1718850-2023-01032
• Device Sequence Number: 20396802
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)170215
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2023
• Report Date (Section F): 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-01-04
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 113 KG