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

Model Number 60-02-50

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient involvement (2648)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that the centrifugal pump displayed an error code.As this occurred during set up, there was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the centrifugal pump system.The incident occured in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the centrifugal pump system displayed an error code.As this occurred during set up, there was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(4) manufactures the centrifugal pump system.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 centrifugal pump system displayed an error code.As this occurred during set up, there was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.While on site, the service representative was unable to reproduce the reported issue.Simulated flow testing was performed and the unit was flowing normally.The service technician updated the software and inspected / tested all components according to the manufacturers specifications.No deviations or errors occurred.Follow up communication with the customer confirmed that they are not having further issues.A review of the dhr could not identify any concessions, deviations or non-conformities relevant to the reported failure.No trend has been identified related to this issue.The issue will be monitored for trends and if identified, corrections will be recommended.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS.
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindbergh strasse 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND GMBH; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4876108
• MDR Text Key: 15231725
• Report Number: 9611109-2015-00228
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,company representative,hea
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• 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