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 Problems Cardiac Arrest (1762); Unspecified Infection (1930)

Event Date 02/21/2021

Event Type  Death  

Manufacturer Narrative

The lot number of the centrimag blood pump was requested but could not be provided.Patient death was previously reported under manufacturer report number 3003306248-2021-01065 under blood pump lot # l0000007.Blood pump lot # l0000007 was exchanged and the patient expired on a the blood pump captured in this report.Manufacturer's investigation conclusion: a direct correlation between the centrimag device and the reported sepsis, hyperkalemia, and patient outcome could not be conclusively established through this evaluation.It was reported that the patient developed severe acute respiratory distress syndrome (ards) and (b)(6) and was transferred hospitals for extracorporeal membrane oxygenation (ecmo) support.About 2 hours into the run the surgeon heard a clicking motor noise from the centrimag pump (manufacturer report number 3003306248-2021-0106).The entire circuit was changed out with a new centrimag pump to resolve the noise.The patient became septic and was hyperkalemic.The patient expired on (b)(6) 2021, and the second centrimag pump was not returned for evaluation.The death was not considered to be device related.The centrimag blood pump instructions for use (ifu) (rev.09) lists infection and death as adverse events that may be associated with the centrimag circulatory support system.This ifu also provides the following warnings and cautions: ifu warning #10: 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 #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient presented to an outside hospital with a witnessed cardiac arrest, ventricular-fibrillation, achieved delayed return of spontaneous circulation (rosc), but coded again in the emergency department.The patient was presented to the cardiac catheterization lab and a stent to right coronary artery (rca) and intra-aortic balloon pump was placed and removed 3 days later.The patient developed severe acute respiratory distress syndrome (ards) and (b)(6).The patient transferred hospitals for extracorporeal membrane oxygenation (ecmo) support.The patient became septic and was hyperkalemic.The patient developed st depression and rapidly progressed to asystole.The patient expired on (b)(6) 2021 and the death was not considered device related.

Manufacturer Narrative

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 CA 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: 12554955
• MDR Text Key: 274041220
• Report Number: 2916596-2021-05430
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• 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
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 135 KG