MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH RPD150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Catalog Number	10-90-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the essenza pump.The incident occurred in the netherland.Pump can be used since this error is resolved.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 prcedure, the essenza rpd150 pump displayed error indicating deviation of the observed direction of rotation from the set direction of rotation (e2350) and stopped.After turning the knob to zero (0) and back to initial flow the pump started again.Procedure could be finished.There is no report of any patient injury.
Additional Manufacturer Narrative
The involved pump is a left vent pump connected to cu.Log provided and found to be empty.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Udi related data quality updates only.D.4.This supplemental report is sent as correction to the previous submitted mdr to correct format of the udi code which was initially provided without parentheses and with missing or wrong digits.The correct udi code has been updated in the dedicated section d.4.Primary unique device identification (udi) number.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: field service technician onsite was unable to reproduce the issue and the affected roller pump and its control unit were requested back to manufacturer for further analysis.Internal visual inspection was performed, in particular, the control unit and the roller pump were opened: the electrical and mechanical connections and boards have been checked and no sign of damage or loose contact has been found.Moreover, a prolonged stress test in climate chamber was performed with no failure reported.The pump was fully functional and never stop nor shown any error message.Based on all the above, possible hardware deviation was excluded and an isolated loss of communication between the pump and the motor control (hms) board (responsible of the detection of direction) issue cannot be ruled out.In digital communication, an exception typically refers to an abnormal or unexpected condition or event that disrupts the normal flow or operation of a system or process.Exceptions are associated with errors or issues that occur during the transmission, processing, or reception of digital data.For example: transmission errors: these occur when data is corrupted during its transmission from one point to another.This can happen due to various factors such as noise, interference, or signal degradation in the communication channel.Timeouts: timeout exceptions occur when there is a delay in receiving a response within a specified time frame.This can be due to network congestion, hardware failures, or other issues.
Event or Problem Description
See initial report.

• Brand Name: RPD150
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• 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: 18309614
• Report Number: 9611109-2023-00634
• Device Sequence Number: 6783813
• Product Code: DTQ
• UDI-Device Identifier: 04033817902997
• UDI-Public: (01)04033817902997(11)230220
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K232291
• 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,Followup,Followup
• Report Date (Section B): 08/14/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 10-90-00
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 11/23/2023; 07/04/2024; 08/14/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 12/12/2023; 08/02/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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