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 Pumping Stopped (1503)

Patient Problem No Patient involvement (2648)

Event Date 04/06/2015

Event Type  Other  

Event Description

Sorin group received a report that the centrifugal pump locked up during a setup.There was no pt involvement.

Manufacturer Narrative

Pt info was not provided.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 received a report that the centrifugal pump locked up during a setup.There was no pt involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.See scanned page.

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The control panel of the centrifugal pump system was returned to livanova (b)(4) for investigation.Visual inspection did not identify any abnormalities or defects.Functional testing and a hardware analysis were unable to reproduce the reported issue.As the issue could not be reproduced, a root cause was not determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• 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 D 809 39; GM D 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 4747696
• MDR Text Key: 5706472
• Report Number: 9611109-2015-00130
• 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,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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