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

Model Number 102953

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/05/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a type a aortic dissection in the context of a left centrimag implant and ultimately passed away.

Event Description

The patient's death was not thought to be device related.The device operated as expected.The centrimag blood pump had been exchanged, however the reason for the exchange was not provided.The exchange was not due to the pump's performance.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the centrimag blood pump and the reported aortic dissection and patient outcome could not be determined through this evaluation.The account reported two possible lot numbers for the centrimag blood pump and could not determine which one was correct.Review of the device history record (dhr) for the centrimag blood pump, lot number l06968-la1 revealed no deviations from manufacturing or quality assurance specifications.Review of the dhr for the centrimag blood pump, lot number l06969-la8 revealed no deviations from manufacturing or quality assurance specifications.The outside of united states (ous) centrimag blood pump instructions for use (ifu) list warnings and cautions regarding the use of the centrimag circulatory support system: ifu warning #9: possible side effects include, but are not limited to: infection, mechanical failure, hemolysis, end organ dysfunction, neurologic dysfunction, bleeding, and embolic phenomena.These are potential side effects with all mechanical circulatory support systems ifu warning #15: 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 #16: potential risk to the patient should be evaluated prior to changing a centrimag vad.Ifu warning #17: 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 #14: always have a spare centrimag vad, centrimag back-up console and spare equipment readily available for change.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• 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: 15448354
• MDR Text Key: 300170349
• Report Number: 3003306248-2022-12506
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 11/08/2022
• 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): Death