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

Model Number	60-01-35
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5) emergency drive.The incident occurred in rionegro, colombia.The customer in not using the hlm since he's waiting for replacement of the device.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 a failure occurred during hand crank process with a cp5 emergency drive unit.Reportedly, the transmission of the movement was not possible apparently for decoupling of the wire.The customer shared photos and video of the issue showing the damage of the wire cover and stated that device was not handled badly and it was not stored in bad conditions.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The unit was sent to the manufacturer for repair and the bowden cable has been replaced to solve the issue.All functional tests positively passed, and the unit was put back into service.Complaints database analysis revealed no similar event since unit installation in 2021.In order to prevent this issue, the ifu states that the drive shaft of the emergency unit should be stored in a horizontal position only and never be kinked.The most likely root cause of the claimed event is a rough handling by the user and/or use condition at customer site.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15638118
• Report Number: 9611109-2022-00531
• Device Sequence Number: 5882297
• Product Code: DWA
• UDI-Device Identifier: 04033817900955
• UDI-Public: (01)04033817900955(11)210610
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/07/2023

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: 60-01-35
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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