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

Model Number 60-02-60

Device Problems Failure to Prime (1492); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Device has not been returned to sorin group (b)(4).Sorin group manufactures the sorin centrifugal pump 5 (cp5).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 touch screen of the cp5 control panel locked up during priming.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the touch screen of the cp5 control panel locked up during priming.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5).The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the touch screen of the cp5 control panel locked up during priming.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.The reported issue was reproducible.The touch screen and hk board were replaced and the software was updated.Subsequent testing found no further issues with the unit and it was released to the customer.The complained unit was returned to sorin group usa for further investigation.The issue was reproduced.Visual inspection did not identify any abnormalities or defects.Photographs were taken and sent to sorin group (b)(4) for further evaluation.Inspection of the photographs identified no signs of fluid penetration.The itoresmeas message that was displayed during testing occurs when there is a deviation between present and past measured current resistance values.This suggests that the issue was caused by a defective component on the hk board.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group deutschland will continue to monitor the market for trends related to this type of issue.

Manufacturer Narrative

Manufacture date provided in initial medwatch report submitted outside of reliance was incorrect.The correct manufacture date is 09/12/2012.As per e-mail from (b)(6) 2021 livanova is submitting this follow-up in replacement of the already provided medwatch 9611109-2016-00090 due to the fact that the reference provided was incorrect.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5408877
• MDR Text Key: 37721909
• Report Number: 9611109-2016-00007
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 01/05/2016

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: 05/01/2016; 05/01/2016
• Supplement Dates FDA Received: 02/18/2021; 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2013
• 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