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

Model Number	60-02-60
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that during procedure, following sudden power failure in the hospital, centrifugal pump 5 (cp5) could not rotate.Then, hand-crank procedure was performed, but the centrifugal pump continued to not rotate and the effective blood flow could not be achieved; raised the drop speed of norepinephrine and the oxygen concentration of the ventilator.After the main power supply regained, centrifugal pump was put into s5 machine and the operation started again.There was no patient injury.
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).Through follow-up communication, livanova learned that after the main power supply regained, the procedure was completed successfully and vital signs of the patient was stable after the procedure.The unit was returned to the manufacturer's site for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: the affected part was returned to livanova deutschland for a detailed investigation.The investigator could confirm the reported issue.In order to solve it, flexible shaft cable will be replaced.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.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Functional verification checks were performed and passed positively.The unit returned to service.A device service history review has been performed and identified that the unit was manufactured in 2020 and no other similar events have been reported.Based on the collected elements, the cause of the failure has been traced back to a faulty component.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 GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17448712
• Report Number: 9611109-2023-00376
• Device Sequence Number: 15295333
• Product Code: DWA
• UDI-Device Identifier: 04033817900955
• UDI-Public: (01)04033817900955(11)201117
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-02-60
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 11/07/2023; 01/31/2024
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 12/06/2023; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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