MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; CENTRIFUGAL BLOOD PUMP

Model Number 102953

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

The patient age, gender and weight was not provided.The serial number of the device is not known, therefore the age of the device cannot be determined.No further information is available at this time.A supplemental report will be submitted when manufacturer's investigation is completed.

Event Description

The patient was being supported with an extracorporeal circulatory support pump.It was reported that the motor started to make a funny noise (suspected clot), and was hot to touch.The console screen went blank.The team was not able to make any adjustment was unable to emergently stop the pump.The emergent shut off was un-responsive.The team removed the motor from the back of the console and placed the same motor into a secondary console.Switching the motor resolved the issue.The alarm which had been produced during this event was thought to be the s3 alarm.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of blank console display and a s3 alarm was not confirmed.The centrimag blood pump was not returned for analysis.Multiple attempts were made to retrieve additional information, but no additional information was provided.The root cause for the reported event of blank console display and a s3 alarm was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: CENTRIFUGAL BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8353902
• MDR Text Key: 136853029
• Report Number: 2916596-2019-00747
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2019

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: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 05/30/2019; 08/01/2019
• Supplement Dates FDA Received: 06/21/2019; 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1