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

Model Number 10-80-00

Device Problems Failure to Pump (1502); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(4).This medwatch report is filed on behalf of sorin group (b)(4).A sorin group field service representative was dispatched to the facility to investigate the issue.The service representative tested the pump alarms and performed a serial read out of the pump memory.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 s5 roller pump did not start during priming.The pressure symbol was yellow.The perfusionist tried to restart the pump and override the alarm but was unable to start the pump.The pin settings had to be reset to start the pump.During the procedure, the master pump displayed the override symbol for the level sensor.However, the level alarm was in use and working properly.The override switched off on its own after about 20 minutes.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).In-house investigation revealed the following: the read out had neither hardware nor software failure stored in the microcontroller.The root causes were determined : the first issue was caused due the close adjustment of the pressure set limits and the second issue was caused from the cardio technician and not from the pump itself, in the read out we found the activation of the function ' module override ', the technician has activated it for 5 minutes.It was recommended to the hospital to set the control limit value over the stop limit value in order to eliminate the control mode function.A review of the dhr did not identify any deviations or nonconformities relevant to the reported issue.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• 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: 6191925
• MDR Text Key: 62914923
• Report Number: 9611109-2016-00905
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: 010403381790038211160204
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/18/2017

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: 10-80-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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