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

Model Number 10-80-00

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).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 roller pump displayed an incorrect flow during procedure.There was no report of patient injury.

Event Description

See initial.

Manufacturer Narrative

A livanova field service representative was dispatched onsite to investigate and could confirm the reported issue.He found out that the switches on the motor control board were not in the correct position.This led to the reported event.The technician set the switches in the correct position and the issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

• 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: 8389415
• MDR Text Key: 139425112
• Report Number: 9611109-2019-00127
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• 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: 04/11/2019

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: 02/05/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1