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 Hemorrhage/Bleeding (1888); Renal Failure (2041); Cardiogenic Shock (2262); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/16/2021

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.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 renal dysfunction.Continuous renal replacement therapy (crrt) was initiated on (b)(6) 2021 (before centrimag implant) and the subject then had no urine output.The patient was reported to have a high volume output from chest tube, the patient was required to go to the operating room for a procedure.Blood products were administered.The patient passed away on (b)(6) 2021 due to multiorgan failure from cardiogenic shock.No additional information was provided.

Manufacturer Narrative

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

Event Description

It was reported that the patient was admitted on (b)(6) 2021 due to worsening shortness of breath on even mild exertion and at rest, severe orthopnea, and worsening lower extremity edema.Transthoracic echocardiography (tte) on admission visualized the apical septal ventricular septal defect (vsd).Left ventricular ejection fraction (lvef) was noted to be 40%, and severe tricuspid regurgitation and mild mitral regurgitation were reported.The patient continued to decline and on (b)(6) 2021 the patient underwent a right heart catheter and intra-aortic balloon pump (iabp) placement.The patient was taken to the operating room for urgent ventricular septal defect (vsd) repair and central extracorporeal membrane oxygenation (ecmo) placement.The patient had a bedside chest washout on (b)(6) 2021 with improvement in chest wall bleeding from the sternal fracture.The patient remained critically ill on ecmo and crrt with significant coagulopathy.On (b)(6) 2021 after extensive discussion with the family and poor prognosis, the decision was made to withdraw care.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the reported events and the centrimag device could not be conclusively established through this evaluation.Review of the device history record (dhr) for the centrimag blood pump revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) lists bleeding, multiple types of organ failure and dysfunction (hepatic dysfunction, renal dysfunction, respiratory failure, and right heart failure), 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 7: it is intended that systemic anticoagulation be utilized while the 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 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.

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 CH-80 05; SZ CH-8005
• MDR Report Key: 12120468
• MDR Text Key: 259988654
• Report Number: 3003306248-2021-02988
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• 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,Followup,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: 70140115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 63 YR
• Patient Weight: 143