MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-03-00

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump console.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group field service representative followed-up with the customer who informed the service representative that the issue occurred when the perfusionist attempted to modify the flow of the centrifugal pump by turning the shaft encoder.The investigation is on-going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the sorin centrifugal pump of the sorin centrifugal pump console stopped after an alarm occurred during a procedure.An error message was displayed on the control panel.The customer turned the control panel off and back on and the sorin centrifugal pump restarted.The procedure was continued without further issue.There was no report of patient injury.

Manufacturer Narrative

(b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova group (b)(4).During follow-up communication with the customer, the livanova field service representative was inform that the system had been used in another case since the incident without issue.The service representative was dispatched to the facility to investigate.The device was tested and the reported error could not be reproduced.The cpu board was replaced together with the shaft encoder as a precaution and additional testing was performed without issue.The system was returned to service.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.Evaluated on site by livanova rep.

• Brand Name: SORIN CENTRIFUGAL PUMP CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 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: 6160047
• MDR Text Key: 62335308
• Report Number: 9611109-2016-00824
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K020571
• 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: 05/05/2017

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: 60-03-00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2002
• 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