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

Model Number 10-85-00

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A distributor engineer replaced an internal board to resolve the issue.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.Device not returned.

Event Description

Livanova (b)(4) received a report that an s5 double head pump showed a graphical display error during a procedure.The touch screen reportedly did not function.There was no report of patient injury.

Manufacturer Narrative

The replaced board was returned to livanova (b)(4) for further investigation.During evaluation, the reported failure was confirmed and the root cause was determined to be a faulty inductor could be identified.The board was scrapped.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6995200
• MDR Text Key: 91917746
• Report Number: 9611109-2017-00880
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900405
• UDI-Public: 010403381790040511160810
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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: 10-85-00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/01/2017
• Supplement Dates Manufacturer Received: 02/22/2018
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1