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 Codes	Pumping Stopped (1503); Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
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.
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 competitor 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 competitor coupler adaptor 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
See initial report.
Additional Manufacturer Narrative
Through follow-up communication, livanova learned that the user was using an adaptor to combine the scp drive with a competitor disposable pump.Moreover, it has been reported that user did not reduce the rpms to zero to rule out decoupling of the drive motor/adapter plate/medtronic pump head.They also did not attempt to hand-crank.According to the user, there was an issue with the disposable adapter to connect the drive with the competitor pump or a user error.To rule out a livanova equipment malfunction, the hlm system, the cp5 panel and the scp drive unit has been checked by a trained biomed in charge and no issue was detected.Based on all the above facts, any livanova hardware malfunction on the equipment can be ruled out as the root cause of the event.It cannot be excluded that issues related to the circuit adapter or to the operating conditions (such as clottings) could have led to the observed decreased blood flow.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: CP5 DRIVE UNIT (WITH CABLE)
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18092413
• Report Number: 9611109-2023-00596
• Device Sequence Number: 5884539
• 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
• 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
• Report Date (Section B): 02/28/2024

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
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2017
• 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 Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 113 KG