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 Low Blood Pressure/ Hypotension (1914)

Event Date 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the s5 roller pump 150.The incident occurred in france.Livanova intiated and investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received report that a s5 roller pump 150 pump made an overspeed alarm durin procedure.Specifically, after 5 minutes of cec, the arterial pump stopped for the first time and restarted by itself.Then 30 seconds later the arterial pump stopped again without the possibility of restarting it and displayed alarm: "acceleration error".Medical team, rescued the procedure with emergency hand crank, changed the arterial pump out and resumed the cec.The patient experience hypotension for approximately 1 minute.There is not report of any patient injury.

• 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 ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 19133049
• MDR Text Key: 340683230
• Report Number: 9611109-2024-00186
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/19/2024

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: 03/19/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2009
• 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