MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S3 MAST PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Model Number 50-70-60

Device Problem Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the s3 mast pump.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 speed potentiometer of the s3 mast pump was found to be out of tolerance during maintenance.There was no patient involvement.The sorin group field service representative tested the speed potentiometer with an external measuring device according the preventive maintenance guidelines and found the speed potentiometer to be defective.The speed potentiometer was replaced and the pump was tested.No further issues were identified.A technical safety inspection was successfully performed and the pump returned to service.The replaced speed potentiometer was inadvertently discarded and could not be returned to sorin group (b)(4) for further investigation.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 deutschland will continue to monitor for trends related to this type of issue.Eval on site by (b)(4) rep; parts discarded.

Event Description

Sorin group (b)(4) received a report that the speed potentiometer of the s3 mast pump was found to be out of tolerance during maintenance.There was no patient involvement.

Manufacturer Narrative

The manufacture date provided in the initial report was incorrect.The correct manufacture date is 02/08/2002.

• Brand Name: S3 MAST PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• 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: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5810984
• MDR Text Key: 50068044
• Report Number: 9611109-2016-00439
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K972321
• 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
• Report Date: 06/21/2016

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: 50-70-60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2002
• 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