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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/31/2022

Event Type  Death  

Event Description

It was reported that the patient experienced major bleeding and peri-cannula bleeding on (b)(6) 2022.The patient passed away.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.Initial reporter phone number: (b)(6).

Manufacturer Narrative

Correction: the initial report was incorrectly submitted with a cfn-based manufacturer report (mfr) number: 2916596-2023-00161.The mfr number should have been fei-based with the 10 digit fei being (b)(4).Manufacturer's investigation conclusion: the reported events, as well as a direct correlation to the centrimag blood pump could not conclusively be determined through this evaluation.The centrimag blood instructions for use (ifu) lists bleeding and death as adverse events that may be associated with the centrimag circulatory support system.The ifu states that it is intended that systemic anticoagulation be utilized while the device is in use and anticoagulation levels should be determined by the physician based on risks and benefits to the patient.The device history record for centrimag blood pump lot #l07705-la5 (document dhr cm pump (b)(4)) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) (rev.E) lists bleeding and death as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.This ifu also provides the following warnings and cautions: 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 #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.

Event Description

Additional information was received that there was massive bleeding from the outflow cannula close to the aorta.The bleeding was treated surgically.It was not considered to be device related and the device operated as expected.The patient was stable, awakening, and weaning off of mechanical ventilation.

• 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: 16184913
• MDR Text Key: 307489329
• Report Number: 2916596-2023-00161
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• 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: 03/02/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 201-90010
• Device Catalogue Number: 102953
• Device Lot Number: L07705-LA5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• 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