MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 DOUBLE ROLLER PUMP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	DRP 85
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 double roller pump 85 head malfunctioned when it was in service.It was the blood pump on the cardioplegia double header.The affected pump has been replaced with a spare one.No additional information is available so far.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5 double roller pump 85.The incident occurred in london, united kingdom.The unit will be shipped to livanova deutschland for a detailed investigation and repair.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: the affected part was returned to livanova deutschland for repair and serial read-out of the pump (real time device parameters and setting recording file) were extracted and analyzed.Several "master_control_stop" errors were found at around 13:40.At the same time (13:36-13:40) several occurrences of motor control failure - error code 442 ("no_pulse_block" text) were registered in the pump logs.During the inspection of the pump, the error "shaft angle encoder fault pump a" was confirmed.As troubleshooting the encoder was replaced.Functional test passed positively and device returned to regular service.A device service history review has been performed and identified that the unit was manufactured in 2020 and no other similar event has been reported, neither concerning trend has been identified.Based on all the gathered information, it is reasonable to assume that the most likely root cause of the reported issue was a failure of the shaft encoder while the "no_pulse_block" error was most likely related to procedure/usage of the pump, rather than a malfunction of the pump itself.

• Brand Name: S5 DOUBLE ROLLER PUMP 85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 20407313
• Report Number: 9611109-2024-00458
• Device Sequence Number: 6517904
• Product Code: DTQ
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)200902
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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: DRP 85
• Device Catalogue Number: 10-85-00
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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