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

Model Number 28-95-80

Device Problems Decreased Pump Speed (1500); Increased Pump Speed (1501)

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

Event Date 07/15/2022

Event Type  malfunction  

Event Description

Livanova received a report that the control panel of a s5 mast roller pump could no longer be operated and the pump speed could not be adjusted.Reportedly, at the same time the touchscreen function froze and the switching to change from tubing /2 inch to 3/8 inch did not work.No error message was displayed.A loaner device was provided to the customer.The issue occurred during priming and there was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 mast roller pump.The incident occurred in muenchen, germany.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: the involved pump was manufactured in 2013 and according to the analysis of the complaints database no further similar events have been reported in the past.A livanova field service technician was dispatched to the customer facility to check and test the pump.During the visit on site: the touchscreen issue was confirmed.The touchscreen of the roller pump was found to be frozen.The issue with the tubing size which could not be changes from 1/2 to 3/8 could not be reproduced.The issue related to the not adjustable pump speed could not be reproduced.No problem was detected during the tests performed.The roller pump was found spinning properly and no components replacement was deemed necessary.Troubleshooting revealed that the touchscreen malfunction was caused by fluid ingress into the touchscreen.Most likely, the tubing size could no longer be changed because of the touchscreen issue, due to the fluid ingress into the touchscreen.Based on the results of the tests performed on site, the touchscreen malfunction is unrelated to the not adjustable pump speed.Taking into account that the speed of the pump could be properly adjusted during the tests performed by the authorized livanova field service technician, it cannot be ruled out that an intermittent issue with the processor board / intermittent communication between the processor board and the shaft encoder, solved during the reseating of the connections carried out as part of the touchscreen replacement, could have led to the reported issue.The unit was tested after the touchscreen replacement and returned to service in its expected function.

• 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: 15182970
• MDR Text Key: 298044977
• Report Number: 9611109-2022-00402
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071318
• 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: 08/08/2022

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: 28-95-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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