MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP, CAN; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90016

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the patient was placed on palliative care after an echocardiogram (echo) revealed a thrombus in the patient's left ventricle had obliterated their cavity.The patient experienced low flow alarms.It was noted that the patient had previously used a centrimag for left ventricular support.The patient passed away on (b)(6)2023 due to hypoxic arrest.The death was not thought to be device or therapy related.Related heartmate 3 pump mfr #: 2916596-2023-02741.

Manufacturer Narrative

Event date was estimated as date of use of centrimag could not be provided.Device lot number was unable to be provided.Manufacturer's investigation conclusion: a direct correlation between the report of a left ventricle thrombus and the centrimag device could not be conclusively established through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The centrimag blood pump was not returned for evaluation.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The centrimag blood pump instructions for use (ifu) (rev.G) is currently available.The ifu contains the following additional warnings and precautions: ifu warning #10: possible side effects include, but are not limited to: embolic phenomena.Ifu warning #16: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #17: potential risk to the patient should be evaluated prior to changing a centrimag vad.Ifu warning #18: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #10: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #14: always have a spare centrimag blood pump, back-up console, and equipment available for change out.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP, CAN
• 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: 17000193
• MDR Text Key: 315910345
• Report Number: 3003306248-2023-01931
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening
• Patient Sex: Female
• Patient Weight: 57 KG