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 Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Hemothorax (1896); Pleural Effusion (2010); Pulmonary Edema (2020); Tachycardia (2095); Thromboembolism (2654); Epistaxis (4458)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

This event was originally reported under mfr # 3003306248-2021-02979.This report is being submitted to address the events occurring on the pump that the patient was exchanged to on (b)(6) 2021.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer report number: 3003306248-2021-02979.It was reported that the patient received 1 unit of red blood cells on (b)(6) 2021 for bleeding with increased oozing around tracheostomy on (b)(6) 2021.Patient experienced hemoglobin drop to 7.0.The patient experienced infection on (b)(6) 2021.The patient was started on intravenous antibiotic administration on (b)(6) 2021 following multiple days of leukocytosis.Cultures that were taken found to be positive for micrococcus species (suspected to be skin flora).The patients central venous catheter was removed.The event resolved without sequelae on (b)(6) 2021.The patient was given 1 unit of red blood cell on (b)(6) 2021 for generalized hemoglobin management.The goal was to keep the hemoglobin values above 7.0.The source of bleeding was not specified.The patient was given another unit of red blood cell on (b)(6) 2021 for continued hemoglobin management.The patient underwent a exploratory laparotomy procedure with noted pneumatosis seen on abdominal computed tomography scan on (b)(6) 2021.The patient experienced continued bleeding following procedure and 4 red blood cell units were given.The patient was started on intravenous antibiotic therapies on (b)(6) 2021 following noted pneumatosis/enteritis on computed tomography scan alongside increasing lactate.The patient received 3 units of red blood cells on (b)(6) 2021 with noted excessive bleeding coming from the patients driveline exit site.The patient experienced decreasing hemoglobin levels below 8 on (b)(6) 2021 with associated anemia.This required hemoglobin replenishment and the patient was given 1 unit of red blood cells on (b)(6) 2021.The patient experienced hemolysis on (b)(6) 2021.Patient was noted to have increasing lactate dehydrogenase labs with a value on 1163 units/liter, 1222 units/liter and 1462 units/liter from (b)(6) 2021.The patient had increasing plasma free hemoglobin with a level of 65.1 milligrams/deciliter on (b)(6) 2021.And 126.5 milligrams/deciliter on (b)(6) 2021.The patient required hemoglobin management with consistent decrease in hemoglobin lab values.The patient's centrimag pump was replaced on (b)(6) 2021 due to device thrombus.The patient was in ongoing/stable condition at time of the event.It was reported that the patient experienced decreasing hemoglobin to below 7.5 on (b)(6) 2021 with suspected multifactorial sources.Hemoglobin management was necessary since the patient was on anticoagulation.1 unit of red blood cells was given on (b)(6) 2021.Hemolysis resolved without sequelae on (b)(6) 2021.The patient received 1 unit of red blood cells on (b)(6) 2021 for continued hemoglobin management.Chest computed tomography scan on (b)(6) 2021 showed bilateral pleural effusions.Bilateral chest tubes were placed with thick purulent drainage output following placement.The patient was started on intravenous antibiotic therapy.A arterial non-central nervous system thromboembolism was noted on (b)(6) 2021.Patients chest computed tomography scan showed evidence multiple pulmonary emboli with patient requiring increased oxygen.Abdominal computed tomography scan taken on (b)(6) 2021 showed evidence of acute cholecystitis.Gall bladder distension and thickening alongside increasing lipase and lactate was noted.The patient was started on intravenous antibiotics.The patient was given 3 units of red blood cell units between (b)(6) 2021 following thrombectomy procedure.The patient experienced increased output from around right and left chest tubes following placement on (b)(6) 2021.The patient was started on tissue plasminogen activator/dornase regimen as appropriate for occlusion prophylaxis and given 4 units of red blood cells.The patient underwent video-assisted thoracoscopic surgery on (b)(6) 2021 for hemothorax removal.They were given 1 unit of red blood cells during procedure.The bleeding continued following procedure with increased hemorrhaging.The patient then received 2 units of red blood cells with return back to the operating room for exploration purposes on (b)(6) 2021.The patient returned to the operating room on (b)(6) 2021 for continued exploration/washout and chest closure with the patient receiving 6 units of red blood cells during the procedures.The patient received 1 units of red blood cells to keep hemoglobin levels about 7.5.Additional information revealed that the patient also received 2 units red blood cells on (b)(6) 2021, 2 units on (b)(6) 2021 and 1 unit on (b)(6) 2021 due to bleeding.A thrombectomy procedure was performed on (b)(6) 2021 to address venous thromboembolism.The patient experienced continued epistaxis from (b)(6) 2021 and was given nasal packing.The patient experienced increasing white blood cell count on (b)(6) 2021 with positive resulting beta-d glucan.The patient was started on intravenous antibiotic therapies.The patient was started on intravenous antibiotic therapies as appropriate on (b)(6) 2021.A hepatobiliary iminodiacetic acid scan done on (b)(6) 2021 indicated suspected acute cholecystitis with gall bladder wall thickening.The patient was started on empiric intravenous antibiotics with chole drain placement done on (b)(6) 2021.The patient experienced continued epistaxis on (b)(6) 2021 with otorhinolaryngology being consulted.The patient was given 1 unit of red blood cells on (b)(6) 2021 for continued epistaxis.The patients lab resulted positive for enterobacteria cloacae on (b)(6) 2021.The patient was given 1 unit of red blood cells on (b)(6) 2021 following suspected pull on chole drain and decrease in hemoglobin with additional suture being placed.Computed tomography imaging also showed hemoperitoneum near uterus with possible association to drain placement.The patient was given 1 unit of red blood cells on (b)(6) 2021 in association to decreasing hemoglobin.The cause of decreasing hemoglobin was unclear but it was speculated to be multifactorial.

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 the patient was given (b)(6) unit of red blood cells on (b)(6) 2021, (b)(6) 2021 and (b)(6) 2021 due to decreasing hemoglobin.Patient re-consulted with psychiatry group on (b)(6) 2021 for continued medication management.The patient was reintubated on 26aug2021 for hypoxia and hypercapnia due to increased pulmonary edema.Bronchoscopy was performed which showed no signs of obstruction.The patient was extubated on the morning of (b)(6) 2021.The event resolved without sequelae on 29aug2021.The patient expressed necessity of increase respiratory support with persistent opacities and pleural effusions being seen in chest imaging.The patient was started on antibiotic therapies with suspect of possible pneumonia.Pleural fluid was taken on (b)(6) 2021 which resulted positive for enterococcus faecalis with continuation of antibiotics as appropriate.

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.The centrimag device has not been returned for evaluation at this time.Review of the device history record (dhr) for the centrimag blood pump, lot # l06849-la8 revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump us instructions for use (rev.09) lists bleeding, infection, cardiac arrhythmias and peripheral thromboembolism as adverse events that may be associated with the use of the centrimag circulatory support system.This ifu also provides the following warnings and cautions: ifu 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 #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 warning #23: the safety and effectiveness of use of the centrimag system for use > 30 days has not been demonstrated.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

It was reported that the patient's original infection resolved on (b)(6) 2021.It was reported that the patient was given one unit of rbcs in association to decreasing hemoglobin on (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021.On (b)(6) 2021 the patient was noted to have increased ventricular response with concern of tachycardia.The patient was given intravenous (iv) magnesium and lidocaine bolus and demonstrated an appropriate response.On (b)(6) 2021 the patient received a chest x-ray that exhibited an increase in bilateral opacities with more heterogeneous opacity in the right lower lung.The patient had sputum cultures taken with resulting gram positive rod and coccus on (b)(6) 2021 and was started on iv antibiotic therapies as appropriate.On (b)(6) 2021 antibiotics were discontinued after the infection resolved.

• 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: 12335919
• MDR Text Key: 267044618
• Report Number: 3003306248-2021-04024
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2023
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L06849-LA8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• 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; Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 75 KG