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

Model Number	60-02-60
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).The cp5 system was tested by the hospital biomedical engineer trained by livanova and couldn t reproduce any problem.Through follow-up communication livanova learned that the device is in use at the customer site.If any additional information pertinent to the reported event is received, it will be provided in a supplemental biomedical engineer of the hospital checked the device.
Event or Problem Description
Livanova received report that a cp5 centrifugal pump suddenly turned off on its own during cpb while supporting patient prior to the aortic cross clamp being applied.With the console off no forward flow was being delivered by the cpb pump to the patient.Reportedly, cpb had only been commenced for under 10 minutes and the patient still had a closed heart with a perfusable rhythm when the incident occurred.Clamping out the arterial and venous lines were performed to prevent further blood volume from the patient to be drained into the cpb reservoir.Lines were re-clamped out and pump console troubleshooted but it was not possible to identify issue as to why the drive console turned off.The centrifugal pump was hand-cranked while the drive unit and the control panel were replaced.The patient was stable and no serious injury occurred and cpb restarted with new cp5 system.
Additional Manufacturer Narrative
H.10: based on collected information and considering, that the unit is still in use without showing further deviations.The most likely, root cause of the reported event is traced back to a temporary missing communication between the cp5 panel and cp5 drive unit.Solved by switching, the cp5 system off and on again and / or by reseating the cp5 drive unit connector on the cp5 panel.
Event or Problem Description
See initial report.

• 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: 14853426
• Report Number: 9611109-2022-00317
• Device Sequence Number: 17470489
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)170627
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/29/2022

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: 03/03/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2017
• 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 Sex: Unknown