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 Consequences Or Impact To Patient (2199)

Event Date 06/21/2015

Event Type  malfunction  

Event Description

Sorin group received a report that the centrifugal pump was not reading flows properly during a procedure.There was no report of patient injury.

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the centrifugal pump system.The incident occurred in (b)(4).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the centrifugal pump was not reading flows properly during a procedure.There was no patient injury.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).A sorin group field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported malfunction.Further investigation of the device revealed that the failure was caused by a defective board.The board was replaced to resolve the issue and subsequent testing did not reveal any further failures.The device was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• 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; munchen 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 4932588
• MDR Text Key: 6015742
• Report Number: 9611109-2015-00276
• 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: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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