MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90010

Device Problem Mechanical Problem (1384)

Patient Problem Thrombus (2101)

Event Date 02/15/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of thrombus within the centrimag blood pump could not be confirmed through this evaluation because the blood pump was disposed and no photographs showing the presence of device thrombosis were submitted by the account.The ous centrimag vad ifu lists embolic phenomena as a possible side effect that may be associated with the use of the centrimag vad and warns the user to monitor the circuit carefully for any signs of occlusion.The device history record was reviewed and showed that the device was manufactured in accordance with manufacturing and quality assurance specifications.No further information was provided.The patient remains ongoing on centrimag support with the new blood pump.The manufacturer is closing the file on this event.

Event Description

It was reported that the hospital perfusionist noticed a thrombus in the blood pump of the left side centrimag for a patient on biventricular circulatory support.The blood pump was exchanged and the patient is doing well on the new pump.No further information was provided.The thrombus in the patient's right side is reported under mfr # 3003306248-2020-00010.

• Brand Name: CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 9849235
• MDR Text Key: 189324418
• Report Number: 3003306248-2020-00009
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 7640135140030
• UDI-Public: (01)7640135140030(10)L06322-LA4
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 201-90010
• Device Lot Number: L06322-LA4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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: 45 YR
• Patient Weight: 54