MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 CONTROL PANEL MAST ROLLER PUMP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 28-95-80

Device Problems Device Operational Issue (2914); Human Factors Issue (2948)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the s5 control panel mast roller pump 150/85.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 control panel mast roller pump was accidentally turned off during a procedure when the user hit the switch while moving another part of the device.The customer suggests better protection of the power switch.There was no patient injury.This issue is customer dissatisfaction and not a product malfunction, as the device is working according to specification.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.No trend was identified for this type of issue.Sorin group (b)(4) will continue to monitor the market for trends related to this type of issue.Pictures were sent to explain the issue.

Event Description

Sorin group (b)(4) received a report that the s5 control panel mast roller pump was accidentally turned off during a procedure when the user hit the switch while moving another part of the device.The customer suggests better protection of the power switch.There was no patient injury.

• Brand Name: S5 CONTROL PANEL MAST ROLLER PUMP 150/85
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5520420
• MDR Text Key: 41020729
• Report Number: 9611109-2016-00121
• 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: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28-95-80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2011
• 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