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 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

H10: livanova deutschland manufactures the s5 roller pump.The incident occurred japan.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that, the icon of the level control of a roller 150 pump was not displayed even though a level sensor was set on.Customer attempted to resolve the issue by the pump off/on with pressing its power switch at the bottom of pump itself.They pressed the switch to turn off once and then pushed again for turn on, and it was found that the switch popping out as their hands off.The power was unable to stay on.The customer placed a rubber cap under the pump to stay pushing the switch to continue the procedure.That was completed without stopping ecc.There is a high possibility that the switch section is malfunctioning.There is no report of any patient injury.The procedure was performed with ¿closed circuit¿, and the affected pump was used as ¿volume control pump¿.Therefore, the power switch failure did not affect the procedure itself since a main pump was working normally during this event.The level sensor is not suspected to have any failure.

• 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 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; lindberghstrasse 25; munich, CO 80309
• MDR Report Key: 19103851
• MDR Text Key: 340906890
• Report Number: 9611109-2024-00179
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/08/2024

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2014
• 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