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

Model Number 201-90052

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2023

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

It was reported that the pedimag was not flowing due to a clot in the device.Per intensivist, the patient was 1 month old on pedimag and typically flows 0.2-0.4 rpms.Heartcare provider notified abbott because flows were down to 0-0.15 lpm and flows had been low for days.The low flow alarms had been turned off as well.The patient had a computed tomography (ct) scan and echocardiogram (echo) which showed that patient's heart was functioning appropriately and stronger.Surgical team was aware but did not want to intervene.The healthcare provider reported there was clotting all over the cannulas and tubing, but were unable to see if there was a thrombus in the impeller.Patient was anticoagulated on bivalirudin.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events could not be conclusively determined, and increased clot burden could not be confirmed as no images were submitted for review and the device was not returned for evaluation.A direct correlation between the reported events and the pedimag blood pump could not be conclusively established through this evaluation.The pedimag blood pump, lot # 8868806, was not returned for evaluation.Review of the device history record (dhr) for the pedimag (pm) blood pump (dhr pm pump l08256-lb5/8868806) revealed no deviations from manufacturing or quality assurance specifications.The pedimag blood pump instructions for use (ifu), document (b)(4), rev 04 lists embolic phenomena as possible side effects that may be associated with the use of the pedimag blood pump (ifu warning #3).The ifu cautions that placing a tubing clamp near a tubing connection point can damage the connector, resulting in thrombus formation at the area of damage (in the section titled ¿recommended pumphead priming procedure¿).The subsection titled indications for use explains that the pedimag blood pump is indicated for use with the centrimag console and motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation.It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.G.Valvuloplasty, surgery of the vena cava or aorta, liver transplants etc.).The ifu contains the following additional warnings and cautions: ifu warning #1: the pedimag blood pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.E., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or for extracorporeal membrane oxygenation.Ifu warning #9: 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 #12: frequent patient and device monitoring is required.Ifu warning #17: monitor the patient¿s hemodynamics and console flow display to insure adequate blood volume for the inlet cannula position, blood pump rpm (revolutions per minute), 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 #18: 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 #23: use of this pump for periods longer than durations appropriate to cardiopulmonary bypass procedures may result in pump failure, reduced pumping capacity, excessive blood trauma, degradation of blood contact materials with possibility of particles passing through the blood circuit 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 #6: attach tubing to the pump in such a manner as to prevent kinks or restrictions that may alter flow or cause regions of stasis or turbulence.Attach in a manner that does not bend or fracture the tubing connectors or ports.Advance the tubing beyond the second barb point of the pump connectors.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a spare pedimag blood pump, back-up console, motor, and accessories available for change out.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient¿s pedimag blood pump was exchanged on (b)(6) 2023 due to increased fibrin/clot burden; refer to the investigation of the original pedimag blood pump (lot # l08132-lb5).It was reported on (b)(6) 2023 that the patient had typical flows of 0.2-0.4 liters per minute (lpm), but pump flows had been low for days, ranging from 0.0-0.15 lpm.The patient had a ct (computed tomography) scan and echocardiogram that showed the patient¿s heart was functioning appropriately and stronger.There was clot all over the cannulas and tubing, but thrombus could not be visualized in the impeller.It was noted that the patient was anticoagulated at that time.It was reported that the inflow cannula apex position was challenging due to the patient¿s small, fibrotic left ventricle, with flows under 0.2 lpm occurring frequently.Due to the patient¿s recent embolic stroke (addressed under the investigation of the original pedimag blood pump (lot # l08132-lb5)), cannula strategy was not changed.The inflow cannula change to atrial position was planned for (b)(6) 2023.The pedimag blood pump was exchanged due to clot burden in the tubing connectors on (b)(6) 2023; it was noted that the pump head was clean.Related manufacturer report number for original pedimag blood pump (lot # l08132-lb5): 3003306248-2023-05047.

• Brand Name: PEDIMAG 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: 17385163
• MDR Text Key: 319749882
• Report Number: 3003306248-2023-01965
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140634
• UDI-Public: 07640135140634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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: 201-90052
• Device Lot Number: 8868806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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): Required Intervention
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 3 KG