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

Model Number 10-88-00

Device Problems No Display/Image (1183); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.As the reported issue could be intermitted the technician decided to replace the touch screen and the processor board.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A serial readout was sent to livanova (b)(4) for further investigation.During the evaluation the reported issue could be confirmed and an issue with the communication between the processor board and the motor endstage board could be identified.Therefore the pump was requested back for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 a s5 mast roller pump stopped and the display went blank during procedure.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

Through the evaluation of the readout the reported issue could not be confirmed.The livanova deutschland investigator was able to identify some deviations on (b)(6) 2018, however, the event date was stated to be (b)(6) 2018.The read out shows no deviations with the hkr board.The deviation stored in the microcontroller could derive from residues of dried fluid on the pcb´s or a poor connection between main panel and the pump itself or the main switch of the mast panel.To evaluate the specific issue in this case the whole pump has been requested for investigation, however, the requested part has not been made available.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S5 MAST ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8202255
• MDR Text Key: 131592983
• Report Number: 9611109-2018-01443
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K062396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1