MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-60

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5).The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The device has been requested for return to sorin group (b)(4).A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the control panel of the sorin centrifugal pump 5 (cp5) performed a restart on its own during a procedure.After restarting, both the open and close icons for the arterial clamp appeared on the display when the clamp was closed.There was no report of patient injury.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 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: 6115068
• MDR Text Key: 60426228
• Report Number: 9611109-2016-00767
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112225
• 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
• Report Date: 10/24/2016

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: 60-02-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2013
• 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