MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number	60-03-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of a scpc centrifugal pump speed control knob defective.The issue was identified during priming.There was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the centrifugal pump console.The incident occurred in erlangen, germany.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The knob was fixed and the issue could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: through follow-up communication livanova learned that the reported issue was only related to knob being loose and that the pump speed could still be regulated via the speed control knob.The reported issue is not likely to result in serious injury.Therefore, reportability decision changes to not reportable event.
Event or Problem Description
See initial report.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 15146246
• Report Number: 9611109-2022-00378
• Device Sequence Number: 14889991
• Product Code: KFM
• UDI-Device Identifier: 04033817901013
• UDI-Public: (01)04033817901013(11)200319
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K020571
• 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): 08/01/2022

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: 60-03-00
• 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: 07/04/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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