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

Model Number	60-03-75
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known patient involvement.Livanova (b)(4) manufactures the scp control panel.The incident occurred in (b)(6).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
Livanova received report about a control knob not working sometimes.No patient involvement reported.
Additional Manufacturer Narrative
There was no known patient involvement.Livanova (b)(4) manufactures the scp control panel.The incident occurred in (b)(6).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
Livanova received report about a control knob not working sometimes.No patient involvement reported.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H.10: no technical service has been scheduled yet at the customer's site.Moreover, it was not possible to clarify whether the customer despite the reported issue with the knob was still able to control the pump speed.Thus, conservatively this case remains reportable.The analysis of the complaint database did not reveal further reported issues related to this unit since its installation on the field (in 2018).Based on similar cases, the issue can be related to loose knob or to malfunction affecting pump speed control.If the knob is loose, it doesn't necessarily impact pump speed control.The user may experience some difficulties in knob rotation and still be able to regulate rpms.In case of pump speed control issue, the user would not be able to regulate rpms through knob rotation.Based on investigation for similar cases, the most likely root cause would be a shaft angle encoder failure.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 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: 13168178
• Report Number: 9611109-2022-00002
• Device Sequence Number: 14476867
• Product Code: KFM
• UDI-Device Identifier: 04033817901020
• UDI-Public: 010403381790102011181105
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 60-03-75
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2018
• 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