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 Bacterial Infection (1735); Sepsis (2067); Fungal Infection (2419)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Specific patient information and device serial number are documented as unknown.Date of event has been entered as the same as published date since date of data collection was not provided the initial analysis of infectious adverse events in pediatric ventricular assist devices reported to the action registry n.Bansal, et al.The journal of heart and lung transplantation, 01 apr 2022.Doi: 10.1016/j.Healun.2022.01.178 additional mfr #2916596-2022-11519.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported through the research article "the initial analysis of infectious adverse events in pediatric ventricular assist devices reported to the action registry" identifying that heartmate 3 may be related to sepsis, driveline infection, and pump infection.The centrimag device was also identified in this cohort study, vad data from the action registry from sep2018 to aug2021 were analyzed.Cohort was divided by device type as paracorporeal (pc) (centrimag) and intracorporeal (ic) (heartmate 3) to describe infection adverse events (iae).Of the 506 patients, 139 patients (27.5%) experienced at least one iae.Majority were sepsis (77, 34.5%) or localized non device related (77, 34.5%), 51 (22.9%) being iae of percutaneous site and only 4 (1.8%) were pump related.Median time to first device related iae was 40 days.Infections were bacterial in 121 (46.5%), fungal in 10 (3.86%) and unknown in 119 (46%).Upon comparison, patients on pc devices were significantly younger (0.81 vs 15.2 years), smaller (0.39 vs 1.46 m2), and sicker (intermacs profile1 and 2, ecmo at implant and ventilator support; all p values <0.05) than patients on ic.There was no difference in gender, diagnosis, and dialysis frequency between devices.Pc devices had a significantly higher iae rate and had significantly more sepsis iae.Device related iae were significantly higher in hm3 than hvad [17 (47.2%) vs 7 (17.9%), which seem to be driven by driveline infections.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported infections or sepsis could not be conclusively determined through this evaluation, and a direct correlation between the centrimag blood pump and the reported events could not be conclusively established through this evaluation.Specific centrimag blood pump lot numbers were not provided, and no product was available for evaluation.The applicable lot numbers of the centrimag blood pumps associated with the reported events were not provided and were unable to be identified.The us (united states) centrimag blood pump instructions for use (ifu) lists infection as an adverse event that may be associated with the centrimag circulatory support system under ¿adverse events¿.This ifu also provides the following warnings and cautions: ifu warning #10: frequent patient and device monitoring is recommended.Ifu warning #13: the pump must be handled in an aseptic manner until primed and connected to a closed tubing circuit.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

Related manufacturer reference number: 2916596-2022-11519.

• 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 CA CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14622637
• MDR Text Key: 294643540
• Report Number: 2916596-2022-11521
• 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: Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2022
• 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): Other; Hospitalization