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 Renal Failure (2041); Sepsis (2067); Cardiogenic Shock (2262); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Gastrointestinal Hemorrhage (4476); Liver Failure (4492)

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had immediate post operation course complicated by worsening right ventricular (rv) failure, which persisted despite escalating doses of inotropes and pressors.The left ventricle appeared underfilled and the patient remained oliguric with high right sided filling pressures.The patient was brought back to the operating room for right ventricular assist device (rvad) placement with extracorporeal membrane oxygenation (ecmo).Support was slowly ramped up to achieve good drainage and saturations.Transesophageal echocardiography (tee) post showed balanced septum with inotrope and pressor requirements being minimal.The patient was also given inhaled nitric oxide.It was reported that the right ventricle dysfunction moderately to severe reduced existed pre-implant.The peak pressure was 31 mmhg.A device related issue did not cause/contribute to the right heart failure.A right ventricular assist device (rvad)/extracorporeal membrane oxygenation (ecmo) was placed.The patient passed away due to bi-ventricular dysfunction, renal failure, cardiogenic shock, worsening liver failure, sepsis, gastrointestinal bleeding, and respiratory failure on (b)(6) 2021.The patient withdrew care.The death was not device related and the device operated as expected.Related manufacturer report number of pump: 2916596-2021-03500.

Manufacturer Narrative

Manufacturer's investigation findings: a specific cause for the report of sepsis could not be conclusively determined.Additionally, a direct correlation between the reported events and the centrimag device could not be conclusively established through this evaluation.It was reported that the centrimag device would not be returned for evaluation.The us (united states) centrimag blood pump instructions for use (ifu) lists bleeding, infection, and multiple types of organ failure and dysfunction (hepatic dysfunction, renal dysfunction, respiratory failure, and right heart failure) 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 ifu warns to handle the pump in an aseptic manner until primed and connected to a closed tubing circuit.The serial number of the device was not provided; however, the reported event and subsequent investigation do not indicate an issue with the manufacture of the product.The centrimag blood pump instructions for use (ifu) lists bleeding, infection, death, and multiple types of organ failure and dysfunction (hepatic dysfunction, renal dysfunction, respiratory failure, and right heart failure) 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 #7: 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 #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.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
• MDR Report Key: 12451217
• MDR Text Key: 278403675
• Report Number: 3003306248-2021-04021
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 74