MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S3 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-60-00

Device Problems Failure to Pump (1502); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2016

Event Type  No Answer Provided  

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).(b)(4).Sorin group (b)(4) received a report that the s3 roller pump did not circulate following an error message that the user received during setup.The power was cycled off and on, but the pump did not rotate.There was no patient involvement.A sorin group field service representative tested the unit and was able to confirm the reported issue.The service representative identified a defective component on the motor control pcb.The board was replaced to resolve the issue.The service representative was unable to reproduce the error following the replacement.Photos were provided to sorin group (b)(4) and the issue was confirmed.After further communication with the customer, sorin group (b)(4) learned that the pump displayed an error code after turning on of the pump.The user did not notice the error code and continued operating the pump, which led to the reported failure.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.

Event Description

Sorin group (b)(4) received a report that the s3 roller pump did not circulate following an error message that the user received during setup.The power was cycled off and on, but the pump did not rotate.There was no patient involvement.

Manufacturer Narrative

The 510(k) number provided in the initial report, submitted october 12, 2016, was incorrect.The correct 510(k) number is k950990.

• Brand Name: S3 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; sorin group deutschland; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6024840
• MDR Text Key: 57292889
• Report Number: 9611109-2016-00652
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950990
• 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

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: 10-60-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2005
• 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