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 Stroke/CVA (1770); Convulsion/Seizure (4406); Ischemia Stroke (4418); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

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 a one-month-old patient with pedimag (lot 8132-lb5) was believed to have stroke occurred on or before (b)(6) 2023 with new onset sub clinical seizures noted on video electroencephalogram (veeg) on (b)(6) 2023.Computed tomography (ct) scan done on (b)(6) 2023 and confirmed acute embolic stroke.The patient had pedimag tubing/connectors with increased fibrin/clot burden on (b)(6) 2023.Pump and tubing were changed out done on (b)(6) 2023 (new lot 8868806).Clot burden was in tubing at the connectors near the pump.The patient was treated with medication started including keppra, midazolam, phenobarb and phosphenytoin to control seizures, which stopped early morning on (b)(6) 2023.The patient has since been converted to single ventricle physiology and has been weaned from the device.The patient continued to make slow progress but remains intubated and on low dose inotrope therapy.The pedimag was not flowing due to a clot in the pedimag.Per intensivist, typically flows 0.2-0.4 rpms.Heartcare provide 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 had 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 clot all over the cannulas and tubing, but unable to see if there is a thrombus in the impeller.The patient was anticoagulated on bivalirudin.Additional information stated that inflow cannula apex position was challenging due to small fibrotic left ventricle with low flows less the 0.2 occurring frequently.Due to recent embolic stroke, medical team were holding off changing cannula strategy due to risk to head.Pump was changed out due to clot burden in tubing connectors on (b)(4) 2023 (new lot 9071207).Pump head was clean.On (b)(6) 2023, the patient was converted to central cannulation after damas kaye stansel surgical procedure (new lot 8993625).On (b)(6) 2023, pedimag support was discontinued.The patient remained in critical condition intubated sedation multiple inotropes.Related pedimag pump (lot 8868806) is reported under mfr# (b)(4).

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events could not be conclusively determined, and increased fibrin/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 patient was supported via a pedimag blood pump (lot # l08132-lb5), implanted on (b)(6) 2023.The patient experienced an embolic stroke on or before (b)(6) 2023 with new onset of seizures noted on video electroencephalogram.It was noted that the pedimag tubing/connectors had increased fibrin/clot burden on (b)(6) 2023 leading to a pump and tubing exchange on (b)(6) 2023.The discontinued pump head was clean with the clot burden in the tubing at the connectors near the pump.The patient received medication to control seizures until (b)(6) 2023.A computed tomography (ct) scan on (b)(6) 2023 confirmed acute embolic stroke.The pedimag blood pump was not returned for evaluation.Review of the device history record (dhr) for the pedimag (pm) blood pump (dhr pm pump l08132-lb5) revealed no deviations from manufacturing or quality assurance specifications.The pedimag blood pump instructions for use (ifu) rev 04 lists embolic phenomena and neurologic dysfunction 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 #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 #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.

• 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: 17543644
• MDR Text Key: 321156888
• Report Number: 3003306248-2023-05047
• 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: 8132-LB5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/14/2023
• 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: 12/01/2022
• 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