MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90010

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/12/2021

Event Type  Injury  

Event Description

It was reported that the patient was implanted on (b)(6) 2021.The left ventricular assist device (lvad) implantation was done with the help of cardiopulmonary support and diffused pericardial adhesions were noted.The left ventricle was first cored under transesophageal echocardiogram (tee).A pre-existing left ventricular clot was removed and the left ventricle wall was noted to be thin.The apical cuff was sewed with the help of 2-0 pledged sutures.During the outflow graft clip insertion the clip went oblique and got stuck.It was pulled out with the help of a clamp and re-inserted properly.The lvad was started post insertion and they attempted to wean the patient from cardiopulmonary bypass (cpb) support.Due to right ventricular dysfunction post implantation, the patient was put on support using a centrimag.The graft was sewed on the right atrium and pulmonary artery through which cannulas were inserted for right ventricular assist device (rvad) support.There were a couple of attempts to wean from cpb and start the rvad, but while the cannula were being removed from the right atrium air was noticed in the rvad drainage line and the rvad was stopped.The lvad flows came down.The patient was supported with cpb again and the right atrium graft was re-sutured.Cpb time was prolonged.A long venous catheter was inserted in the femoral vein for blood drainage from rvad support.Rvad support was established.A temporary pace maker was inserted and the patient was supported with atrioventricular sequential sensing.There was generalized oozing from the procedure, which required replacement of blood and blood products (frozen free plasma, single donor platelets, and packed red blood cells).The apical cuff suture lines were bleeding and the patient was put on cpb again.Extra sutures with pledgeted suture dugout was done.There was small oozing at the outflow graft clip and the surgeon was worried that the outflow graft was damaged during the push and pull of the outflow graft clip.Bleeding was reduced and later found to be negligible.A new outflow graft and clip were offered, but the surgeon decided they were not necessary.The patient was supported with cell saver and volume was replaced after processing.Total time on cpb was 510 minutes.The patient was transfused with nearly 30 units of packed red blood cells, 16 units of fresh frozen plasma and 3 units of single donor platelets.The patient was also supported with nitric oxide.Systemic vascular resistance was found low and inotropes were increased.After replacements of the components, bleeding was reduced.Considering the continuous oozing and volume replacement, the patient's chest was kept open and covered with ioban/plastic sheet and the patient was moved to the intensive care unit (icu).In the icu the bleeding and general oozing continued and the patient was reexplored.The patient was given a few more units of blood and blood products.Flows were reduced and the surgeon observed rvad flows of 2.7 lpm and lvad flows showing as 0 lpm, which was for quite some time.Later the rvad flows were reduced, as well as overall patient flow.Low flow alarms were noted on the lvad.The patient passed away on (b)(6) 2021 due to multi-system organ failure.Related manufacturer reference number: 2916596-2021-02219.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific root cause for the report of air in the circuit could not be conclusively determined.It was reported that the patient underwent left ventricular assist device (lvad) implantation on (b)(6) 2021.Due to right ventricular dysfunction post implantation, the patient was put on support using a centrimag.Grafts were sewed on the right atrium and pulmonary artery through which cannulas were inserted for right ventricular assist device (rvad) support.There were a couple of attempts to wean from cardiopulmonary bypass (cpb) and start rvad support.While removing the cannula from the right atrium, air was noticed in the rvad drainage line and the rvad was stopped.The lvad flows came down and the patient was supported with cpb again.The right atrium graft was re-sutured.The cpb time was prolonged.A long venous catheter was inserted in the femoral vein for blood drainage to successfully establish rvad support.The patient ultimately passed away on 1(b)(6) 2021 due to multi-system organ failure (refer to the lvad investigation).The centrimag pump was not returned for evaluation.The us centrimag blood pump instructions for use (ifu) cautions the user to monitor the patient¿s hemodynamics and console flow display to ensure adequate blood volume for the inlet cannula position, pump rotations per minute (rpm), and desired flow.Increase the pump rpm in small increments to minimize the risk of exceeding the available blood volume and causing inlet cannula obstruction, suction, outgassing, and/or cavitation.Furthermore, as with all continuous flow pumps, operating at too high a speed can result in negative pressure at the inlet which can lead to collapse of the ventricle or blood vessels, inlet cannula obstruction, inspiration of air, outgassing, cavitation and increased risk of embolism.Always operate the system at the lowest speed consistent with the volume of blood available to be pumped and clinically acceptable circulatory support.The centrimag blood pump instructions for use (ifu) lists the adverse events that may be associated with the centrimag circulatory support system.This ifu also provides the following warnings and cautions: ifu warning #3: massive air entry into the pump will cause the pump to de-prime and blood flow to stop.Clamp the outlet tubing, stop the pump, and remove air prior to resuming circulation.Ifu warming #10: frequent patient and device monitoring is recommended.Ifu warning #15: monitor the patient¿s hemodynamics and the console flow display to ensure adequate blood volume for the inlet cannula position, pump rpm, and desired flow.Increase the pump rpm in small increments to minimize the risk of exceeding the available blood volume and causing inlet cannula obstruction, suction, outgassing, and/or cavitation.Ifu warning #16: as with all continuous flow pumps, operating at too high a speed can result in negative pressure at the inlet which can lead to collapse of the ventricle or blood vessels, inlet cannula obstruction, inspiration of air, outgassing, cavitation and increased risk of embolism.Always operate the system at the lowest speed consistent with the volume of blood available to be pumped and clinically acceptable circulatory support.Ifu warning #20: monitor the pump and tubing for air because the pump, similar to other centrifugal pumps, will pump air immediately.Clamp the pump outlet tubing if air enters the pump as gaseous emboli may be introduced into the patient, with attendant risk of death or severe bodily injury.A massive air embolus will deprime the pump, halting blood flow.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.Furthermore, the ifu states that, ¿actual obtainable flow is dependent on the difference between the preload and afterload of the pump (pump pressure differential, the resistance to flow through the extracorporeal circuit components (cannulas, tubing, etc.) and the patient hemodynamics (intravascular pressures, cardiac output, and available volume)¿ under ¿pressure vs flow graph¿.Review of the device history record (dhr) for the centrimag blood pump, lot # l06852-la2 revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS
• 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: 11803455
• MDR Text Key: 253826039
• Report Number: 3003306248-2021-01105
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: 201-90010
• Device Lot Number: L06852-LA2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention