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 Problems No Display/Image (1183); Device Inoperable (1663); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2015

Event Type  Other  

Manufacturer Narrative

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 display of a centrifugal pump system went dark and became unresponsive during a procedure.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the display of a centrifugal pump system went dark and became unresponsive during a procedure.There was no report of pt injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the centifugal pump system with tubing clamp.The incident occurred in (b)(6).(b)(4).A loaner device was provided to the customer.A livanova field service representative contacted the customer and asked that the defective device be returned to livanova (b)(4) for further investigation.However, the device was not returned.Preventative maintenance was performed on the device at a later date without malfunction.Livanova (b)(4) believes the customer was able to resolve the issue on their own.As the device was not investigated, a root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device not returned by customer.

• Brand Name: SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 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: 5060717
• MDR Text Key: 25226418
• Report Number: 9611109-2015-00320
• 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: Unknown
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• 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
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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