MAUDE Adverse Event Report: LIVANOVA DEUTCHSLAND SORIN CENTRIFUGAL PUMP 5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-01-04

Device Problems No Display/Image (1183); Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.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 received a report that the sorin centrifugal pump 5 did not display values and the centrifugal pump did not turn when the unit was ramped up during priming.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate and was able to reproduce the reported issue.A new drive unit was resolved and a functional verification was performed.No further issues were found and the unit was returned to service.The replaced device has been requested for further investigation.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 5 did not display values and the centrifugal pump did not turn when the unit was ramped up during priming.There was no patient involvement.

Manufacturer Narrative

This is a follow up to the initial mdr submitted.After further investigation, it was determined the reported issue could be reproduced and it was caused by a short circuit at the soldering joints of one component which led to the failure of 2 other components on the motor control pcb zpr 0801.After resoldering of these 3 components no further issues were identified during testing.Corrections were made to manufacturer, mfr site to reflect manufacturer name change and updated contact information.

• Brand Name: SORIN CENTRIFUGAL PUMP 5
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTCHSLAND; 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: 5488106
• MDR Text Key: 39935842
• Report Number: 9611109-2016-00119
• 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
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-04
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• 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