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

Model Number 10-80-00

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the magnet of the pump cover was found to be missing from the s5 roller pump.This issue was discovered by a sorin group field service representative during routine maintenance, so there was no patient involvement.The service representative replaced the pump cover to resolve the issue.The replaced pump cover has been discarded.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Evaluated on site by rep; discarded.

Event Description

Sorin group (b)(4) received a report that the magnet of the pump cover was found to be missing from the s5 roller pump.This issue was discovered by a sorin group field service representative during routine maintenance, so there was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The issue was resolved by replacement of the pump cover.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.This is a known issue for which a capa (b)(4) has been initiated to perform a design change of the pump cover.Change order 9509 has already been implemented as a correction.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: 5710900
• MDR Text Key: 47202609
• Report Number: 9611109-2016-00389
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• 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
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2006
• 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