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

Model Number 10-80-00

Device Problem Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(4).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 of a s5 roller pump shutdown during priming.The pump was replaced with a backup device.There was no patient involvement.

Manufacturer Narrative

H.10: no additional information about service activity performed on this specific device has been provided to livanova.However, this type of issue is mostly related to electric/electronic defective components of the pump itself and to communication failure between pump circuit boards.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

The serial read out of the affected pump was analyzed and the roller pump was further investigated.It was confirmed that the pump is unable to boot.Considering the age of the pump, it cannot be ruled out that he reported event was most likely caused by a computer board failure.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9577234
• MDR Text Key: 174623124
• Report Number: 9611109-2020-00014
• 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,Followup
• Report Date: 01/10/2020

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: 10-80-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 03/04/2020; 07/21/2020
• Supplement Dates FDA Received: 04/02/2020; 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1