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

Model Number 28-95-80

Device Problems No Display/Image (1183); Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 control panel mast 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 touch screen of the s5 control panel mast roller pump became unresponsive to touch during priming.There was no patient involvement.The s5 control panel mast roller pump was returned to sorin group (b)(4) for repair.The reported issue was confirmed and the complained touch screen was replaced with an led touch screen.Subsequent testing found no further issues and the pump was returned to the hospital.The replaced touch screen was inadvertently discarded by service, so a root cause could not be determined and no corrective actions were identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

Event Description

Sorin group (b)(4) received a report that the touch screen of the s5 control panel mast roller pump became unresponsive to touch during priming.There was no patient involvement.

• Brand Name: S5 CONTROL PANEL MAST ROLLER PUMP 150
• 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: 5954991
• MDR Text Key: 54882530
• Report Number: 9611109-2016-00643
• 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
• Report Date: 08/11/2016

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: 28-95-80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2011
• 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