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

Model Number 10-80-00

Device Problems Failure to Pump (1502); Device Displays Incorrect Message (2591); Human Factors Issue (2948)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.(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 s5 roller pump displayed an error code during a procedure.There was no report of patient injury.A sorin group field service representative contacted the customer to provide tech support.The customer stated that, after receiving the error message, the pump was switched out and the procedure was continued with no additional problems.During the technical support call, the service representative learned that the issue was caused by an operator error.The involved pump was set as a cardioplegia pump utilizing the dual tubing method in the raceway.The tubing got twisted and resulted in the reported error message.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 for trends related to this type of issue.Technical support provided via phone.

Event Description

Sorin group (b)(4) received a report that the s5 roller pump displayed an error code during a procedure.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: 6012762
• MDR Text Key: 56964183
• Report Number: 9611109-2016-00639
• 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: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2014
• 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