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

Model Number 201-20003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Hemolysis (1886); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Low Pulmonary Arterial Wedge Pressure (2479); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/14/2022

Event Type  Injury  

Event Description

It was reported that the patient had bleeding from needle holes during a chest closure procedure on (b)(6) 2022.They received a blood transfusion of 5 units of pack red blood cells (prbc's).Hemoglobin dropped to less than 6.6 gm/dl.After the transfusion, the hemoglobin was stable at 9.8gm/dl.The patient was left with their chest wound open and drains in place.The patient returned to the operating room (or) on (b)(6) 2022 for chest closure as bleeding was controlled hemoglobin was at 8.2gm/dl.The patient continued to have elevated plasma-free hemoglobin of 90mg/dl on (b)(6) 2022 and 80mg/dl on (b)(6) 2022.On (b)(6) 2022, the patient noted feeling something wet on the right side of their neck.The clinician assessed the patient and noted bleeding from the swan-ganz catheter.The swan-ganz catheter's side port was dislodged and pressure was held to the site.The patient's mean arterial pressure (map) dropped to 56mmhg for which they received 16mcg of epinephrine via iv push.A red cap was placed on the the side port which stopped the bleeding and the map stabilized to 80 mmhg.The patient's white blood cell (wbc) trended upwards at 16.6 on (b)(6) 2022.Blood cultures were drawn and the patient was given a 1000mg vancomycin iv and started on a 2gm course of cefepime every 8 hours for 5 days.On (b)(6) 2022, the patient had an increasingly strong coughs.They had no signs of a fever.The patient's wbcs were still elevated at 19.3 after antibiotic treatment.A chest x-ray was performed and found stable.On 27mar the patient went into atrial fibrillation (afib) with a heart rate of 99bpm.The patient was started on continuous infusion of an amiodarone iv bolus.Their heart rate was controlled and the amiodarone iv was discontinued.On (b)(6) 2022, the patient had acute encephalopathy with altered mental state and increased agitation.A computed tomography (ct) of the patient head revealed no acute findings.On (b)(6) 2022, a blood test returned positive for fungitell.The patient began micafungin.The electroencephalogram (eeg) showed moderate cortical dysfunction but could not find any seizure activity.There was concern that cefepime iv treatment-induced toxicity.The patient was taken off cefepime and put on 2gm iv ceftazidime every 8 hours instead.They were started on a daily 1250mg iv of vancomycin.On the evening of (b)(6) 2022, the patient was hypotensive and in afib with rapid ventricular rate (afib rvr).The patient's heart rate was in the 140 for which they received 150mg iv bolus of amiodarone, 1gm iv of calcium chloride, and 2mg iv of magnesium sulfate.The patient's heart rate become better controlled at 98 bpm.The patent's mean arterial pressure (map) was in the 50's and their central venous pressure (cvp) was elevated to 17-29 mmhg.Their norepinephrine was increased to.15 mcg/kg/min.Their dobutamine was increased to 7.5 mcg/kg/min for right ventricular support.The patient also continued to have continuous renal replacement therapy (crrt).On (b)(6) 2022 the patient experienced right heart failure, the patient received a right ventricular assist device (rvad), the rvad was removed on (b)(6) 2022.On (b)(6) 2022, the patient had continued leukocytosis with wbcs at 16.1.Blood cultures were negative and the chest x-ray was stable.

Manufacturer Narrative

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

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The patient received a right ventricular assist device (rvad) with an lvad for right heart failure after worsening symptoms on (b)(6) 2022.The rvad was removed on (b)(6) 2022.Additional information revealed a non-occlusive deep vein thrombosis on an ultrasound performed on (b)(6) 2022.The patient was placed on a heparin drip.The patient was put on inhaled nitric oxide on (b)(6) 2022 and as a result the patient's mixed venous oxygen saturation (sv02) decreased.The patient was initially given milrinone (primacor) but was too hypotensive.This was stopped and norepinephrine was restarted.The patient continued to have poor right ventricular function so they continued their use of vasoactive medications.The patient had a history of atrial fibrillation and had an implantable cardioverter-defibrillator (icd) implanted prior to the left ventricular assist device.The patient's arrhythmia did not resolve but was treated to control the pump flow rate.

Event Description

Additional information revealed that the patient had another afib rvr on (b)(6) 2022.The patient was given 150mg iv amiodarone (pacerone).Electrophysiology was consulted on (b)(6) 2022.A plan for a transesophageal echocardiogram (tee) and cardioversion was made.The patient was weaned off of nitric oxide and epinephrine.

Manufacturer Narrative

Manufacturer's investigation conclusion.The reported events, as well as a direct correlation to the centrimag blood pump could not conclusively be determined through this evaluation.The us (united states) centrimag blood pump instructions for use (ifu) lists neurological dysfunction, bleeding, cardiac arrhythmia, infection, right heart failure, and arterial non-cns thromboembolism as adverse events that may be associated with the centrimag circulatory support system.Additionally, this ifu states that the pump is intended to be used with systemic anticoagulation and anticoagulation levels should be determined by the physician based on risks and benefits to the patient.The centrimag blood pump instructions for use (ifu), rev.09, lists neurological dysfunction, bleeding, cardiac arrhythmia, infection, right heart failure, and arterial non-cns thromboembolism 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 #19: do not restart the pump if the pump has been stopped for more than 5 minutes without adequate anticoagulation, as the risk of thromboembolism is increased after blood has remained stagnant in the pump, extracorporeal circuit, connectors, and cannulae.Ifu warning #21: use of the pump for periods longer than 30 days may result in pump failure, reduced pumping capacity, excessive blood trauma, and/or degradation of blood contact materials (with possible particles passing through the cannulae to the patient), leaks, and increased potential for gaseous emboli.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The device history record for centrimag blood pump lot # l06851-la5 was reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CMAG 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: 14141348
• MDR Text Key: 289502020
• Report Number: 2916596-2022-10236
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• 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: Foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: 201-20003
• Device Lot Number: L06851-LA5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• 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): Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 80 KG