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

Model Number 10-85-00

Device Problems No Display/Image (1183); Loss of Power (1475); Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group sales representative confirmed that the reported issue was reproducible following the event.Through follow-up communication with the customer, sorin group (b)(4) became aware that this issue had occurred multiple times in the past on (b)(6) 2016.In both cases, the customer continued use of the device, as it restarted right away.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the display of the s5 double head pump disappeared and the device powered off during priming.The pump stopped and restarted after a couple seconds.There was no error indication on the display.There was no patient involvement.

Manufacturer Narrative

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).The involved pump was returned to livanova (b)(4) for further investigation.During evaluation of the returned pump, the issue could immediately be reproduced and was traced back to the hkr 0325 processor board.A serial read out of the pump memory was performed and several deviations were identified.The root cause of the issue was determined to be internal firmware bugs in the micro-controller ic1.This is a known issue and can occur when the pump memory is not deleted after applying a firmware update.To resolve the issue, the pump memory was deleted.The pump was tested extensively and the issue could no longer be reproduced.As a precautionary measure, the processor board was replaced.Following the investigation, a technical safety inspection was performed and no issues were identified (refer (b)(4)).The device was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A field engineering note (b)(4) has been released to inform field service engineers that the memory should be deleted following the firmware update.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP 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: 6220489
• MDR Text Key: 63800143
• Report Number: 9611109-2016-00921
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/03/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2008
• 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