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

Model Number 10-80-00

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 roller pump did not recognize the level sensor during procedure.On the pump display the level sensor symbol was not visible.The perfusionist did however not notice this initially.Only when the level in the oxygenator fell below the sensor level and an alarm sounded without stopping the pump the perfusionist noticed this.Later when the user restarted the s5 the level sensor was active on the pump.The error did not occur again.There was no report of patient injury.

Manufacturer Narrative

H.10: a livanova field service representative was dispatched to the facility to investigate the device and was not able to confirm the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.An improper assignment of the level monitoring function to the pump by the user cannot be excluded.

Event Description

See initial report.

• 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: 9831301
• MDR Text Key: 190901456
• Report Number: 9611109-2020-00183
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

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: 02/12/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1