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

Model Number 102953

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

Patient Problems Obstruction/Occlusion (2422); Thrombocytopenia (4431); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 08/18/2021

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

On (b)(6) 2021 it was reported that during initial hm3 (heartmate 3) implant the patient required placement of protek duo rvad (right ventricular assist device) and ecmo (extracorporeal membrane oxygenation).The patient remained in the operating room (or) during original implant and on bypass for 233 minutes.The patient experienced an intraoperative complication of bleeding, which required a blood transfusion of 10 units of packed red blood cells.There was a lung wedge resection done for chest bleed and the patient¿s chest remained open with plans of returning to the operating room.On (b)(6) 2021, 48 hours post hm3 implant, the patient became thrombocytopenic, received ffp (fresh frozen plasma) and platelets.There was an intraoperative estimated blood loss of 3320 mls.The patient developed an ileus, an ng tube was placed and patient remained nothing by mouth with total parenteral nutrition.The patient developed respiratory compromise and underwent an urgent bronchoscopy where a large mucous plug was removed.The patient remained intubated.On (b)(6) 2021 the patient developed renal dysfunction and a post operative aka.The acute kidney injury (aki) was related to ischemic acute tubular necrosis from cardiogenic shock.Their inotrope dosage was decreased and switched to iv (intravenous) bumex.Creatinine levels rose from.88 to.85 to 2.93.Patient additionally developed postoperative atrial fibrillation with rapid ventricular rate cardioverted.Iv amiodarone was started.The patient developed neurologic dysfunction (neuromuscular dysfunction) where they remained intubated postoperatively day 4 in the icu (intensive care unit).They were felt to be acute toxic/ metabolic encephalopathy.Patient was not withdrawing with pain, decreased sedation, and head ct (computed tomography) showed no acute changes.On (b)(6) 2021 the patient¿s ldh (lactate dehydrogenase) was elevated and thrombus was found in the oxygenator.The rvad speed was decreased and bivalirudin was started instead of heparin.Pf4 (platelet factor 4) was negative for heparin-induced thrombocytopenia (hit).The patient had a 50 second run of supraventricular tachycardia, a singular aicd (automated implantable cardioverter defibrillator) shock, and lidocaine iv drip started.The patient also experienced decreased circulation.The patient had evidence of distal extremity ischemia (fingers ¿ extending to hands, all toes extending to plantar surface and heels bilaterally).There was a loss of pulse in fingers, ashen in color, doppler ultrasound revealed patent arteries but calcifications in ulnar and radial arteries; there was limited visualization due to bandages and ecmo lines.The patient¿s fingers bilaterally have necrotic dark fingers, cool to touch.Demarcate extends on arms and wrists bilaterally feet with black toes.The patient developed leukocytosis with fever, they remained on empiric iv antibiotic cultures with no growth so far.Blood lactate dehydrogenase was increased and with continued respiratory failure and poor peripheral circulation, was unable to be extubated.Iv amiodarone started again and there was a run of ventricular tachycardia on (b)(6) 2021.On (b)(6) 2021 coffee ground ng output tube feeds held.There was no melena or hematochezia.Kub (kidney, ureters, bladder) image was negative.On (b)(6) 2021 patient underwent an esophagogastroduodenoscopy (egd) revealing a 7mm stomach ulcer and esophagitis.Aspirin on hold.The patient has alos and remained on/off inotropes; was stopped day 7 postop but restarted (b)(6) 2021 and remained on rvad.On (b)(6) 2021 possible hypovolemia resulted in low flow alarms and was treated with iv plasmalyte and albumin 25% as fluid resuscitation.On (b)(6) 2021 the log file captured low flow events which did not persist long enough to trigger a low flow alarm.These occurred at times when the pulsatility index was elevated.The low flow alarms resolved.On (b)(6) 2021 the patient received another aicd shock and was sinus tachycardia to normal sinus rhythm afterwards.A tracheostomy tube was placed.On (b)(6) 2021 ultrasound doppler in left upper extremities confirmed radial artery thrombosed.Fever curve 38.8 on/off to 38.2 through to (b)(6) 2021, patient remained on/off empiric iv antibiotic cultures with no growth as of (b)(6) 2021.On (b)(6) 2021 id service was consulted for management and recommendations as no clear source has been identified.Chest ct¿s improving and abdominal ct negative for ischemia.On (b)(6) 2021 the rvad/ecmo was successfully removed due to cannula thrombosis.The patient remained off of iv antibiotics since (b)(6) 2021 but is on iv inotropes in the icu.Patient is not on anticoagulants due to bleeding risks from being thrombocytopenic, risk and active bleeding (both gi and vaginally), currently monitoring circulation.Patient was waiting clinical stability and possible plastic surgery consult.Related heartmate 3 device report: mfr# 2916596-2021-05166.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the centrimag blood pump and the reported cannula thrombosis and elevated lactate dehydrogenase (ldh) could not be conclusively established through this evaluation.The centrimag blood pump was not returned for evaluation.The lot 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 thromboembolism and hemolysis as adverse events that may be associated with the centrimag circulatory support system.The ifu warns the user to monitor the circuit carefully for any signs of occlusion.This ifu also provides the following warnings and cautions: 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 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 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.

• 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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12556232
• MDR Text Key: 278405644
• Report Number: 3003306248-2021-04045
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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 Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 62 KG