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

Model Number	60-03-00
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the sorin centrifugal pump console.The incident occurred in china.In agreement with one of the possible corrective action suggested in the relevant service manual, it was selected to continue to run the pump.As per follow up, the scpc was checked remotely and a fault possibly caused by connection is presumed the root cause.It was concluded the eed to inspect the machine on-site for confirmation.The machine is still in service, no error message after the complaint.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, during a procedure, the scpc intermittently displayed the alarm inconsistent actual value impulses (e78).Meanwhile, the pump was hot to the touch and the flow of blood was unstable.There is no report of any patient injury.The relevant personal could not troubleshoot the problem and the technician could not judge for the cause either: the scpc is currently out of service.
Additional Manufacturer Narrative
H11: as per device service manual, this reported error code, if the pump continues to run, could be due to hall sensor/motor control board connection failure.A device service history review has been performed and identified that the unit was manufactured in 2016 and no other similar events have been reported.Based on the investigation results for similar cases, the reported error code can be due to: defective hall sensor.Defective motor control board.Defective connection between pump control panel and motor control board.Defective connection between hall sensor and motor control board.Defective connecting cable/short circuit.Taking into account that the reported malfunction could not be reproduced after the reported event, it cannot be ruled out that a faulty intermittent connection could have led to the reported event.However, there is no concerning trend for this kind of failure.
Event or Problem Description
See initial report.

• Brand Name: SCPC STOCKERT CENTRIFUGAL PUMP CONSOLE
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19019120
• Report Number: 9611109-2024-00166
• Device Sequence Number: 14423252
• Product Code: KFM
• UDI-Device Identifier: 04033817901013
• UDI-Public: (01)04033817901013(11)160908
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: 60-03-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N.A.
• Patient Sequence Number: 1
• Patient Sex: Unknown