MAUDE Adverse Event Report: MUNICH MAST ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	SRD S5 MAST ROLLER PUMP 150
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a mast roller pump 150, used as arterial one, stopped during a cardiopulmonary bypass (cpb) procedure, after implementing safety measures and initiating total flow cpb.The patient's arterial flow was interrupted for approximately thirty (30) seconds.Also the pump panel stopped the function.There was no patient injury.
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the mast roller pump 150.The incident occurred in bogota, colombia.Further details on the event was received.The main roller pump suddenly stopped, activating audible and visual alarms.Despite attempts, the module did not respond to restore flow.In this situation, the surgical team immediately proceeded to initiate manual flow using the hand crank.The circulatory stop time was approximately thirty (30) seconds.Subsequently, after restarting the equipment, the panel restored its electronic function, and the maneuvers of the procedure resumed.Necessary controls were performed during cpb, recording parameters within acceptable ranges and managing electrolyte deviations.The patient gradually exited the cpb without any additional complications.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.However, as a precaution, it was suggested to use the pump as a suction one for now.The serial read-out of the pump (real time device parameters and setting recording file) was extracted and analysed.In the date of the event, a runaway_peak was recorded.This error message can be due to: - pump hand cranked or manipulated, but not switched off (user error); - hardware reset of the pump (off/on); - defective motor control board/hall sensor in the pump head.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: a review of complaints database confirmed that no similar events have been reported for this unit since its manufacturing date in 2020.Based on investigation findings and serial readout analysis, the most likely root cause of the event is a transient electrical or connection-related disturbance that temporarily interrupted electronic drive/control of the s5 hlm pump.The logged runaway_peak events and the successful restoring of the pump functionalities are consistent with a brief, self-clearing event (e.G., momentary power/connector/communication disturbance) rather than persistent hardware or software failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: MAST ROLLER PUMP 150
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MUNICH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22751628
• Report Number: 9611109-2025-90308
• Device Sequence Number: 20984353
• Product Code: DTQ
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)201211
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/24/2025

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: SRD S5 MAST ROLLER PUMP 150
• Device Catalogue Number: 50-80-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic