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
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.

• Brand Name: S5 DOUBLE ROLLER PUMP 85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; munich 80939 ; GM 80939
• 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: 20407264
• Report Number: 9611109-2024-00457
• Device Sequence Number: 14290748
• 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
• Report Date (Section B): 10/09/2024

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
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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