MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-88-00

Device Problem Pumping Stopped (1503)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in athens, greece.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that during the procedure, the control panel of a s5 mast roller pump overheated and the pump could not be started.Hand crank was performed for approximately 5-6 minutes and then a back up pump was used.There was no report of patient injury.

Manufacturer Narrative

H10: the pump was returned to the manufacturer site for investigation.Variolock with red insert, for 1/4, 5/16 and 3/8 tubings, was mounted on the returned roller pump.Upon power on, the tubing size displayed on the pump panel was 1/2, demonstrating that the tubing size set by the user is different from the one allowed by the variolock tubing insert.A 1/4 tubing was mounted on the pump, using the variolock insert the pump was returned with, and the unit was tested for 6 hours at 250 rpm (maximum allowed speed).No deviations were observed and no error messages were displayed.The pump worked within specifications.Based on all the above information, hardware malfunctions with internal component can be ruled out as cause of the event.It cannot be ruled out that user error (incorrect tubing size set by the customer) could have led to the reported event.

Event Description

See initial report.

• Brand Name: S5 MAST ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 12545506
• MDR Text Key: 273755887
• Report Number: 9611109-2021-00536
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2010
• 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