MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP 150 (S5 RP150); CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that, during a procedure, the s5 roller pump 150 was not performing its function as a sucker pump.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in united states.According to follow up with the customer, the occlusion was not an issue.The perfusionist replace the roller pump with a back-up pump and request a functional inspection be done on the roller pump.A livanova field service engeneer was dispatched to the customer site and connected the complained roller pump to s5 unit to perform functional verification checks per guidelines.However, no error or malfunction of roller pump could be reproduced.Pump was returned to customer and back into service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S5 ROLLER PUMP 150 (S5 RP150)
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17868485
• MDR Text Key: 325365725
• Report Number: 9611109-2023-00491
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)170725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1