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

Model Number 201-90010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 09/16/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ 3 months.The event occurred at (b)(6).The report of thrombus within the blood pump was confirmed through a submitted photograph.The thrombus was situated around the pump rotor, was dark red in color, and appeared to have a stringy structure.The origin and a duration of time for which the thrombus was present in the blood pump could not be determined.A specific cause for the development of the thrombus formation could not be conclusively determined; however, the thrombus was very large and could have contributed to the reported flow below minimum alerts.The blood pump was reportedly disposed by the center and was not available for investigation.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was placed on biventricular extracorporeal circulatory support.It was reported that after approximately 3 months of support, the rvad pump was urgently exchanged due to pump thrombosis.An alarm occurred indicating flow below the limit.No additional information was provided.

• Brand Name: CENTRIMAG BLOOD PUMP, OUS
• Type of Device: CENTRIFUGAL BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7941851
• MDR Text Key: 123047268
• Report Number: 2916596-2018-04163
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 201-90010
• Device Catalogue Number: 201-90010
• Device Lot Number: L05249-LA7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 71