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

Model Number 10-88-60

Device Problem Pumping Stopped (1503)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 control panel mast roller pump 85.The incident occurred in karlsruhe, germany.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 deutschland received a report that a s5 mast roller pump only rotated sporadically during procedure.There was no patient injury.

Manufacturer Narrative

A field service engineer was dispatched to the customer and pump stop could be confirmed.The display and the hkr circuit board were replaced and pump stop again.Cardioplegia module, front panel, ribbon and flat ribbon cables were changed and software updated.No defects found at the time of the stk.Functional tests were successfully passed and unit returned to customer analysis of read out found error message 'timeout_panel_display' was stored in the log file.This error message occurs when there is no signal from the main panel.This confirms that the cardioplegia panel switched off and became dark.For the above, the pump can be ruled out as a potential root cause of the pump stop event, since there is no error message related to a pump failure.Analysis of the read-out suggest the pump stopped due to: stoplink function: the pump was linked to a master pump (master_stop); cardioplegia: the pump stopped when the set amount of cardioplegia was delivered (cplegia_stop, encoder_stop).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

H10: through follow-up communication with field service technician, livanova learned correct model and serial number of the involved s5 mast roller pump affected by the reported issue, that have been added to section d of this report.Moreover, it was learned that the unit is working fine now and no further issues have been detected.Considering follow-up communication and according to the pump serial readout analysis, two issues were identified: 1.The control panel switching off and consequently leading the pump to stop; 2.The pump stop due to cardioplegia control.Indeed the serial read-out (real time device parameters and setting recording file) analysis of the involved pump confirmed that: 1.The error message 'timeout_panel_display' was stored in the log file, this error message occurs when there is no signal from the main panel.This confirms that the control panel switched off and became dark and led the pump to stop.2.Regarding the second issue, there is no error message related to a pump failure.Based on the analysis of the read-out, the pump could be stopped due to: stop-link function: the pump was linked to a master pump (master_stop); cardioplegia: the pump stopped when the set amount of cardioplegia was delivered (cplegia_stop, encoder_stop).A complaints database analysis was carried out and no other similar issues have been submitted for the mast roller pump and its control panel since their installation in 2010.Based on the above facts, the control panel issue was traced back to a faulty computer board (hkr) and the pump stop event was due to the cardioplegia module control.

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; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15959203
• MDR Text Key: 308247423
• Report Number: 9611109-2022-00666
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062396
• 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,Followup
• Report Date: 02/17/2023

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: 10-88-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 02/21/2023; 02/28/2023
• Supplement Dates FDA Received: 02/17/2023; 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2010
• 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