MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SRD S5 SINGLE ROLLER PUMP 150; 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 03/21/2024

Event Type  malfunction  

Event Description

Livanova deutschland received a report that , during installation, the s5 single roller pump 150 pump stopped and displayed alarm with yellow triangle shape including exclamation mark.No other activity was possible when the alarm was displayed.At the time of the first occurrence of the problem, the message 'motor controller failed pump 4' was displayed and, afterward, the message was not longer displayed.Additional tests found the problem recurs intermittently regardless of the operating state.There was no patient involvement.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in south korea.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Through follow up, livanova was informed the problem with the roller pump was a problem during the installation process and the pump was not in use.As a result, the pump was not installed in the hospital and the pump was returned to the distributor.The event has been re-assessed as not reportable since issue was related to an out of box failure and would have been detected anyway prior device use on a patient through the functional tests to be performed at installation phase.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: SRD S5 SINGLE ROLLER PUMP 150
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• 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: 19131987
• MDR Text Key: 341132420
• Report Number: 9611109-2024-00184
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)221007
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K071318
• 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,Followup
• Report Date: 05/21/2024

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
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1