MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-15

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the sorin centrifugal pump system with tubing clamp.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 encoder of the sorin centrifugal pump system with tubing clamp did not work correctly during priming.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.The service representative confirmed that the knob for controlling the pump speed was no longer operational.Troubleshooting identified a loose fastener, which was secured with loctite.Functional tests and a test run did not identify any further issues.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Evaluated on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that the encoder of the sorin centrifugal pump system with tubing clamp did not work correctly during priming.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump system with tubing clamp.The incident occurred in munich, germany.This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the encoder of the sorin centrifugal pump system with tubing clamp did not work correctly during priming.There was no patient involvement.A sorin group field service representative confirmed the issue and identified a loose fastener, which was secured with loctite.Subsequent functional tests and a test run did not identify any further issues.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) has identified the root cause to be normal wear of the device.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Repaired on site by sorin service rep.

• Brand Name: SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, 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: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5693563
• MDR Text Key: 46361842
• Report Number: 9611109-2016-00304
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K032213
• 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: 05/03/2016

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: 60-02-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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