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

Model Number 10-80-00

Device Problem Intermittent Infusion (2341)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device, and confirmed the reported issue.He replaced the touchscreen, processor board, and associated components, and the issue could be solved.Subsequent functional verification testing was completed without further issues, and the unit was returned to service.

Event Description

Livanova (b)(4) received a report that a s5 roller pump stopped intermittently, and the stop function button on the pump display appeared as being pressed during procedure.There was no report of patient injury.

Manufacturer Narrative

H.10: a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Analysis of the provided pictures and the video revealed scratches, dirt and debris on the touchscreen.The root cause of the reported malfunction was traced back to a defective touchscreen.It could not be ruled out that rough handling by the customer (leading to the accumulation of dirt and debris and to scratches on the touscreen) contributed to the reported event.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10733849
• MDR Text Key: 213010803
• Report Number: 9611109-2020-00597
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1