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

Model Number 10-80-00

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).(b)(4).Sorin group received a report that the touch screen of the s5 roller pump experienced an anomaly.The issue was discovered by a sorin representative during preventative maintenance, so there was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the touch screen of the s5 roller pump experienced an anomaly.The issue was discovered by a sorin representative during preventative maintenance, so there was no patient involvement.

Manufacturer Narrative

There have been two field actions for this issue.The z-numbers are z-0956/0965-2011 and z-1149/1158-2012.Livanova (b)(4) manufactures the s5 roller pump.The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The livanova field service representative on site performing routine maintenance replaced the pump with a loaner.A second visit was performed where the service technician replaced the touch screen and the accessories with a new lcd touch screen.The unit was functionally tested without issue and returned to service.Considering the manufacturing year of the pump, livanova (b)(4) believes the most likely root cause is aging and wear of the part and "glude." this is a known issue for which a root cause investigation (b)(4) has been initiated.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova technician.

• Brand Name: S5 ROLLER 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: 5116102
• MDR Text Key: 27195708
• Report Number: 9611109-2015-00405
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 04/10/2017

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0956/0965-2011
• Patient Sequence Number: 1