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

Model Number 10-80-00

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).This issue occurred as a result of user error during the touch screen repair.The customer contacted sorin group on june 10, 2016 for consultation on the repair.The customer declined on-site assistance from a sorin group field service representative and elected to replace the touch screen on their own.Sorin group (b)(4) received a report on july 12, 2016 that, following the cracked touch screen repair performed by the facility biomed, the s5 roller pump would boot up but was unresponsive and displayed warning lights rather than numbers during a procedure.This caused boot-up failures for the display tower.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.The service representatve inspected the pump and discovered that the connections were in the wrong ports, causing the system to be unresponsive.This occurred as a result of the user's unfamiliarity with the touch screen replacement process.The service representative reseated the connections into the propper ports, upgraded the firmware and tested the pump per the service manual.No further issues were discovered and the unit was returned to service.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 deutschland will continue to monitor for trends related to this type of issue.Evaluated on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that, following a cracked touch screen repair performed by the facility biomed, the s5 roller pump would boot up but was unresponsive and displayed warning lights rather than numbers during a procedure.This caused boot-up failures for the display tower.There was no report of patient injury.

• 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): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5870480
• MDR Text Key: 51930843
• Report Number: 9611109-2016-00522
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• 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: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2011
• 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