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); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Thromboembolism (2654)

Event Date 06/02/2022

Event Type  Injury  

Event Description

Related manufacturer report number: 2916596-2022-11596.It was reported that the patient had a lactate dehydrogenase (ldh) spike overnight on (b)(6) 2022.There were no left ventricular assist device (lvad) alarms.A review of the log files revealed no unusual alarms recorded from (b)(6) 2022- (b)(6) 2022.Additional information revealed that the patient was admitted to the intensive care unit (icu) post-operatively for cardiogenic shock.The patient's hemodynamic status was closely monitored with invasive techniques.They remained on epinephrine and milrinone in the post-operative period.The patient was noted as having leukocytosis.Additionally, on (b)(^) 2022, the patient had decreased urinary output and elevated venous pressure.The patient had elevated creatinine levels (2.30 mg/dl).They were started on continuous veno-venous hemofiltration for acute renal failure.On (b)(6) 2022 the patient had signs of restlessness, anxiety, and delirium.Additional information revealed that on (b)(6) 2022 the patient was noted to have acute hypoxic respiratory failure.The patient was on a high flow nasal cannula and was transistioned to a bilevel positive airway pressure (bipap) machine for additional support.A chest x-ray found concerns for pneumonia.Broad spectrum antibiotics were started to treat the presumed pneumonia.Blood cultures were taken and found to be negative for infection.The patient was presumed to have septic shock.On (b)(6) 2022, the patient was taken to the operating room (or) for right ventricular assist device (rvad) implantation due to worsening right ventricular dysfunction as seen on an echocardiogram.Approximately two hours post operation, rvad flow began to drop to 2.6l with associated low flow events on the patient lvad.A bedside echocardiogram showed a dilated rv and a very small left ventricle (lv) cavity.Pump speeds were adjusted but the patient still had low flow events on both their lvad and rvad.The patient was given 3 units of packed red blood cells (prbc's) and 1l of albumin without improvement.A transesophageal echocardiogram was performed to evaluate the rvad's pump position, found a large clot compressing the right atrium.In total the patient received 5 units of prbc's, 4 units of fresh frozen plasma(ffp), 1 unit of platelets, and 1l of iv fluids.

Manufacturer Narrative

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

Manufacturer Narrative

Correction: the initial report was incorrectly submitted with a cfn-based manufacturer report (mfr) number: 2916596-2022-11830.The mfr number should have been fei-based with the 10 digit fei being (b)(4).Section a4: patient privacy laws prohibit the release of private patient information and patient date of birth should have been removed from the previous report.Section d4: device serial number was requested but not provided manufacturer's investigation conclusion a specific cause for the reported peripheral thromboembolism and bleeding as well as a direct correlation with the device could not be determined through this evaluation.It was reported that the patient was implanted with a centrimag blood pump and treated with inotropes due to their worsening rv failure.Approximately two hours post op, rvad flows began to drop to 2.6 l with associated low flow events on lvad.Bedside echo showed dilated right ventricle and very small left ventricle cavity, and the patient was given 3 units packed red blood cells and 1 l of albumin without improvement.A transesophageal echo was performed which found a large clot compressing right atrium.The patient received total 5 units packed red blood cells, 4 units fresh frozen plasma, 1-unit platelets, and 1 l intravenous fluids.The patient remains in the intensive care unit and will continue to be monitored.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and centrimag blood pump.No product is available for investigation.The centrimag blood pump instructions for use (ifu), rev.09, lists arterial non-cns thromboembolism and bleeding as adverse events that may be associated with the centrimag circulatory support system.The ifu states that it is intended that systemic anticoagulation be utilized while the device is in use and anticoagulation levels should be determined by the physician based on risks and benefits to the patient.The ifu warns the user to monitor the circuit carefully for any signs of occlusion.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.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 CA 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: 14842136
• MDR Text Key: 295106118
• Report Number: 2916596-2022-11830
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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?: No
• Device Operator: Health Professional
• Device Model 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: 06/13/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/20/2022
• 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; Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American