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 Anemia (1706); Atrial Fibrillation (1729); Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Necrosis (1971); Thromboembolism (2654)

Event Date 04/02/2021

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 during the patient's procedure, the patient had blood loss anemia.The patient was given 8 units of packed red blood cells, 2 units of platelets, and 4 units of fresh frozen plasma, 20 cryo, 420 cell saver and 2mg of factor 7 throughout the case.The patient's chest was left open, until they were taken back to the operating room on (b)(6) 2021 for closure and was transfused 1 unit of packed red blood cells.Between (b)(6) 2021 and (b)(6) 2021 the patient was transfused an additional 8 united of packed red blood cells.The patient had a trachael aspirate which grew serratia marcescens.The patient was started on antibiotics.The patient also developed renal failure and was started on cvvhd.The patient went into atrial fibrilation with rvr.The patient was given aniodarone bolus twice with resultant heart block.The rate went down to 40s despite ppm set at ddd 70.There was no record of bradycardiac but underlying rhythm aflutter.The epw was turned off due to it competing with ppm.The patient also developed venous thromboembolism.The patient had extremity nectosis to hand and top of nose.Hit positive but sra negative.An ultrasound was performed which noted dvts in right pt and soleal veins, l common femoral vein r ij and subclavian veins.It was reported that on (b)(6) 2021, the patient was taken back to the operating room for a revision sternotomy for emergent evacuation of tamponade.The patient was transfused 1 unit of packed red blood cells and 2 more units on (b)(6) 2021.The patient had a guaiac positive stool, they were transfused 1 unit of packed red blood cells on (b)(6) 2021 and (b)(6) 2021.The patient remained in the icu as stable.The patient was off inotropes.The plan of care was to continue iv antibiotics, bival drip and dialysis.The patient had a consult regarding mediastinitis and necrotic hands.No additional information was provided.

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.Additionally, a specific cause for the reported infection could not be conclusively determined.The centrimag device has not been returned for evaluation at this time.The serial number or other identifying information of the product was not reported and was not able to be determined during the investigation.The centrimag blood pump instructions for use (ifu) lists bleeding, renal dysfunction, infection, venous thromboembolism, and cardiac arrhythmias 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 #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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient received support via a centrimag, and the reported events began on (b)(6) 2021.The patient experienced blood loss anemia during a surgical procedure for aortic root enlargement, aortic valve replacement, and mitral valve replacement.The patient was given intravenous red blood cells, platelets, fresh frozen plasma, cryoprecipitate, cell saver, and a clotting factor.The patient¿s chest was left open, and the patient was taken back to the operating room for chest closure on (b)(6) 2021.The patient received more red blood cell transfusions between(b)(6) 2021.The patient experienced renal dysfunction with anuria on (b)(6) 2021 for which the patient was started on continuous veno-venous hemodialysis.The patient had bacterial growth from a tracheal aspirate on (b)(6) 2021 and was started on antibiotics.The patient experienced a sternal wound infection on (b)(6) 2021 for which the patient received a sternal debridement with washout, wound vacuum placement, and intravenous antibiotics.The patient experienced extremity necrosis on (b)(6) 2021, multiple deep vein thrombi were found with ultrasound, and the patient was found to have heparin-induced thrombocytopenia.The patient experienced atrial fibrillation/atrial flutter with rapid ventricular rate on (b)(6) 2021 for which the patient received an antiarrhythmic medication bolus, and the patient¿s epicardial pacing wires were turned off due to competition with the patient¿s pacemaker.The patient experienced bleeding and was taken back to the operating room on (b)(6) 2021 to redo the sternotomy and evacuate the tamponade.The patient received additional red blood cell transfusions.The patient¿s stool was positive for occult blood on (b)(6) 2021 for which the patient received additional red blood cell transfusions.It was reported on (b)(6) 2021 that the patient remained in the intensive care unit in stable condition and off inotropes.At that time, the patient remained on intravenous antibiotics, blood thinner medication, and dialysis.Plastic surgery was consulted regarding mediastinitis and evaluation of necrotic hands.The patient was discharged to a long-term nursing facility on (b)(6) 2021.It was noted that events surrounding the renal dysfunction, the (b)(6) 2021 infection, and bleeding had resolved, with the deep vein thrombosis and cardiac arrhythmias ongoing.

• 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: 11854589
• MDR Text Key: 251664976
• Report Number: 3003306248-2021-01109
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• 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: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 99