MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102953

Device Problems High Readings (2459); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Thrombus (2101); Blood Loss (2597)

Event Date 03/13/2019

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

The patient was supported by an extracorporeal circulatory support device.It was reported that status post redo-sternotomy with septal myomectomy, subaortic membrane resection, and aortic valve replacement (avr) mechanical on (b)(6) 2019.Operative course significant for large amount of scar tissue, bleeding, and difficulty filling the left ventricle (lv) due to left ventricular outflow tract (lvot) obstruction though it was difficult to quantify due to technically difficult imaging via transesophageal echocardiography (tee) in the operating room (or).Intra-aortic balloon pump (iabp) was attempted in left groin but resulted in large hematoma and procedure aborted, pressure held, and sandbag placed.Imaging of this hematoma later showed no pseudoaneurysm.Central iabp was placed but was not enough support, and this was removed in favor of central cannulation ventricular artery (va) extracorporeal life support (ecls) with centrimag.Post operatively, patient was on high dose vasopressors and inotropes.Patient required multiple blood products.Patient returned to the or the following morning ((b)(6) 2019) for mediastinal exploration and washout.Patient developed rapid atrial fibrillation and was amio loaded and maintained on an infusion.Circuit change out for high lactic dehydrogenase (ldh) and unexplained need for 6 unit transfusion on (b)(6) 2019.Heparin infusion has been held due to bleeding.A clot in the outlet port of the centrimag pump was observed.No additional information was provided.

Manufacturer Narrative

The report of a clot in the outlet port of the centrimag blood pump was confirmed based on a video clip submitted by the account.However, a specific cause for the reported atrial fibrillation and bleeding as well as a direct correlation with the device could not be determined through this evaluation.The video clip submitted by the account revealed a small, tan colored tissue-like deposition within the proximal side of the outlet port of the centrimag blood pump, lot number l05812-la2, while the device was supporting the patient.Part of the deposition appeared to have been adhered to the pump housing.However, this tissue-like deposition was not present within the outlet port upon receipt of the blood pump.Centrimag blood pump, lot number l05812-la2, was returned with approximately 4 inches of tubing attached to the inlet and outlet ports with zip ties.Visual examination of the blood pump revealed no evidence of damage to the pump housing or the inlet/outlet ports.Visual inspection of the inlet port revealed no evidence of depositions or thrombus formations.Examination of the outlet port revealed no evidence of damage.Only traces of loosely coagulated blood were noted within the outlet port with no evidence of any tissue-like depositions or thrombus formations.Examination of the pump rotor and rotor well revealed no evidence of depositions or thrombus formations.Visual inspection of the pump housing revealed a small amount of dark red loosely coagulated blood with no evidence of any tissue-like depositions or thrombus formations.Examination of the pump rotor did not reveal any evidence of damage or wear.Following cleaning, microscopic inspection of the blood pump revealed no anomalies.The blood pump was operated on a mock circulatory loop and functioned as intended in accordance with manufacturing specification.A specific cause for the development of the deposition observed in the submitted video clip, its origin, and a duration of time for which it was present in the blood pump could not be determined through this evaluation; however, its partial obstruction of the blood flow path could have contributed to the reported high ldh levels.The centrimag blood pump ifu lists thromboembolic phenomena and hemolysis as possible side effects that may be associated with the use of the centrimag blood pump.The device history record (dhr cm pump l05812-la2) was reviewed and showed that the device was manufactured in accordance with manufacturing and quality assurance specifications.No further information was provided.The manufacturer is closing the file on the 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
• MDR Report Key: 8460758
• MDR Text Key: 140192048
• Report Number: 2916596-2019-01222
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L05812-LA2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 185