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

Model Number	201-90052
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Second pedimag with flow issue is reported under mfr# 3003306248-2023-01954.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that patient had fibrin formation on connectors of pedimag.The patient was having flow 0.4-0.5 l/min before switching out pedimag on (b)(6) 2023.After pedimag was switched out, patient was only flowing 0.2-0.25 l/min on pedimag.This was reported to clinical on (b)(6) 2023.The patient received fluid and chest tubes without any improvement in flows.Second pedimag with flow issue is reported under mfr# 3003306248-2023-01954.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a specific cause for the reported fibrin formation could not be conclusively determined.A direct correlation between the reported events and the pedimag blood pump could not be conclusively established through this evaluation.Multiple requests for additional information regarding this event were submitted to the account; however, no response has been received at this time.The pedimag blood pump was not returned for evaluation.The pedimag blood pump instructions for use (ifu) 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 #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.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: PEDIMAG BLOOD PUMP
• Common Device Name: 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: 17290874
• Report Number: 3003306248-2023-01964
• Device Sequence Number: 6290835
• Product Code: KFM
• UDI-Device Identifier: 07640135140634
• UDI-Public: 07640135140634
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K090051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: 201-90052
• Device Catalogue Number: 201-90052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 3 KG