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); Thromboembolism (2654)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

The patient's age, gender and weight was not provided.The serial number of the device was requested but was not provided.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that infectious disease (id) consult recommended doxycycline as mycoplasma serologies did return positive immunoglobulin m (igm) and immunoglobulin g (igg) which can be challenging to interpret as igm can remain positive for months after an infection, yet given the uncertainty it would be reasonable to treat with a course of doxycycline.Doxycycline started (b)(6) 2021, vancomycin started (b)(6) 2021.On (b)(6) 2021 ct (computed tomography) showed no intervention indicated for small pseudoaneurysm (< 2 cm) that was mostly clotted off.Followed up with a repeat ultrasound (b)(6) 2021 that showed increased size (5 mm) and was not amenable to percutaneous intervention, would need surgical intervention.Regarding patient's r sfa pseudoaneurysm, ultrasound performed guided compression on (b)(6) 21 with 30 minutes of compression, 5-minute break, then an additional 20 minutes of compression.There did appear to be some decrease in the size of the pseudoaneurysm, but unfortunately there was still pulsatile filling of the defect after ultrasound compression.Obtained formal arterial duplex to confirm whether pseudoaneurysm had changed, but the patient would likely need operative repair.Vascular surgery recommended surgical repair on (b)(6) 2021 and surgery was tentatively scheduled for (b)(6) 2021.Additional information was requested but not provided.

Event Description

Additional information reported that the patient is status-post tricuspid ring annuloplasty, left ventricular assist device (lvad) pump implant, and protek duo centrimag right ventricular assist device (rvad) placement on (b)(6) 2021.The patient began spiking fevers up to 102.5*f and had leukocytosis with white blood count (wbc) jumping from 16.0 to 20.4 10e3/ul on (b)(6) 2021.Mycoplasma pneumoniae immunoglobulin g (igg) and immunoglobulin m (igm) labs were run on (b)(6) 2021 and resulted positive on (b)(6) 2021.Intravenous (iv) doxycycline was administered from (b)(6) 2021.On (b)(6) 2021, venous thromboembolism reported.The patient underwent ct of the chest/abdomen/pelvis with contrast on (b)(6) 2021, at which time nonocclusive thrombus in the right internal jugular and innominate veins were identified.The patient had already started on anticoagulation therapy, so no further changes were made.A follow-up ct had not been done by 30-days post-device removal/time of report, so it is undetermined whether deep vein thrombosis (dvt) has resolved.The patient was consistently spiking fevers and had leukocytosis in the range of 17-18's 10e3/ul despite having started doxycycline therapy for positive mycoplasma pneumoniae igg and igm tests.On (b)(6) 2021, the patient¿s sputum culture resulted positive for klebsiella aerogenes, and they were treated with iv zosyn from (b)(6) 2021.The infection resolved and the patient discharged home on (b)(6) 2021.Vascular access site was also reported on (b)(6) 2021 in which a ct showed: at the time, no intervention indicated for small pseudoaneurysm (<2 cm) that is mostly clotted off.Followed up with a repeat ultrasound (b)(6) 2021 that showed increased size (5mm) and is not amenable to percutaneous intervention, would need surgical intervention.Regarding patient¿s r sfa pseudoaneurism.An ultrasound guided compression was performed on (b)(6) 2021 with 30 minutes of compression.There did appear to be some decrease in the size of the pseudoaneurysm, but unfortunately there was still pulsatile filling of the defect after the ultrasound compression.Vascular surgery recommended surgical repair (elevating this from ae to sae) on (b)(6) 2021.The patient was re-hospitalized on (b)(6) 2021 for surgery.On (b)(6) 2021, the patient underwent repair without complications and was discharged in stable condition on (b)(6) 2021.Outcome resolved without sequelae.No additional information provided.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufactures investigation conclusion: a specific cause for the reported events as well as a direct correlation to centrimag blood pump could not conclusively be determined through this evaluation.It was reported that the patient began having spiking fevers up to 102.5 fahrenheit (f) and had leukocytosis with white blood cells (wbc) ranging from 16.0 to 20.4 10e3/microliters (ul) on (b)(6) 2021.Mycoplasma serologies returned positive for igm/igg on (b)(6) 2021.The patient was started on intravenous (iv) doxycycline on (b)(6) 2021.Vancomycin was started on (b)(6) 2021.A sputum culture was positive for klebsiella aerogenes and were treated with intravenous (iv) zosyn from (b)(6) 2021 through (b)(6) 2021.The infection resolved and the subject was discharged home on (b)(6) 2021.Per additional information, a computer tomography (ct) was performed on (b)(6) 2021 and revealed a small pseudoaneurysm, approximately 2 centimeters (cm), that was mostly clotted off, and no intervention was indicated.A repeat ultrasound was performed on (b)(6) 2021 and revealed the pseudoaneurysm had increased in size.An ultrasound guided compression was performed on (b)(6) 2021 which revealed that there was some decrease in size of the pseudoaneurysm but still presented with pulsatile filing of the defect after compression.Vascular surgery recommended surgical repair.The patient underwent repair on (b)(6) 2021 without complications and was discharged in stable condition on (b)(6) 2021.Per additional information, the patient had a ct scan of their chest/abdomen/pelvis with contrast on (b)(6) 2021, which revealed a non-occlusive thrombus in the right internal jugular and innominate veins were identified.The patient was already started on anticoagulation therapy, so no further changes were made.A follow-up ct was not done 30 days post device removal, so it was undetermined whether the deep vein thromboembolism (dvt) have resolved.Per additional information, it was determined that the reported adverse events were not device related.The lot number for the centrimag blood pump was requested but not provided, additionally, the provided lot number did not correspond with a specific pump.No product is available for investigation.The centrimag blood pump instructions for use (ifu) is currently available.The centrimag blood pump instructions for use (ifu) lists infection, venous thromboembolism, and aneurysm as adverse events that may be associated with the use of the centrimag blood pump.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.Cautions #15: always have a backup centrimag pump, console, motor, and accessories available for use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Frequent patient and device monitoring are recommended.The relevant sections of the device history records for lot number l06824 were reviewed and showed 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
• 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: 12385742
• MDR Text Key: 269274363
• Report Number: 3003306248-2021-04019
• 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,Followup,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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
• Device Lot Number: L06824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 88 KG