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

Model Number	SRD S5 DOUBLE ROLLER PUMP 85
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.11 livanova deustchland manufactures the s5 double roller pump 85, the event occurred in japan.Through follow-up communication it was confirmed that no patient harm occurred.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 about an s5 hlm pump whose cardioplegia dose settings could not be changed, followed by pump stop, resulting in several minutes cardioplegia solution administration delay.Switching the unit on and off allowed the procedure to be completed, without patient impact.Livanova is conservatively reporting this event as serious injury, due to prolonged interruption of procedure.
Additional Manufacturer Narrative
Through follow-up communications, it was learned that the procedure interruption was between 1 to 2 minutes.Based on the above, the event was re-assessed as not reportable, since perfusion interruptions lasting less than 3 minutes due hlm pump stop, without any patient impact and medical interventions, could not cause or contribute to death or serious injury, even if recur.
Event or Problem Description
See initial report.

• Brand Name: SRD S5 DOUBLE ROLLER PUMP 85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTCHLAND; 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 80004
• MDR Report Key: 24471746
• Report Number: 9611109-2026-90068
• Device Sequence Number: 13331467
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SRD S5 DOUBLE ROLLER PUMP 85
• Device Catalogue Number: 10-85-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 03/12/2018
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown