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 Hemolysis (1886); Inflammation (1932); Sepsis (2067); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 12/28/2021

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 patient was admitted on (b)(6) 2021 and was placed on pedimag support on (b)(6) 2021.The hospital team was able to visualize fibrin strands and thrombus in the pedimag circuit and a development of urosepsis and inflammation on (b)(6) 2021 lead to increased fibrin deposition.Based on frequency of transfusions and laboratory evidence of hemolysis, the patient required frequent blood transfusions.The patient¿s hematocrit (hct) 30.9 % down from 36 and required packed red blood cells (prbcs), lactate dehydrogenase (ldh) 1249 u/l, plasma free hemoglobin (hgb) 43.5 g/dl.The team decided to send the patient to the operating room (or) and have the pedimag pump and circuit exchanged.The patient tolerated the procedure well.The patient¿s neuro status was stable and patient was on 8l high-flow nasal cannula and tolerated a slow increase in nasojejunal tube feeds.The team was not concerned with any infection and listed the patient for heart transplant.

Manufacturer Narrative

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

Manufacturer Narrative

Correction on event date.Manufacturer's investigation conclusion: the report of thrombus could not be confirmed through this investigation; no photographs were submitted for review and the device was not returned for evaluation.A direct correlation between the reported events and the pedimag device could not be determined through this evaluation.The pedimag device was not disposed of and exchanged for a new one.The centrimag blood pump instructions for use (ifu) lists thromboembolic phenomena and hemolysis as a possible side effects that may be associated with the use of the centrimag blood pump (ifu warning #3).This ifu also provides the following warnings and cautions: 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 #10: frequent patient and device monitoring is recommended.Ifu warning #14: do not operate the pump for more than 30 seconds in the absence of flow.The temperature within the pump will rise and increased cellular damage and clotting may result.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 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.The device history record for the pedimag blood pump, lot number l06049-lb2, was 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.

Manufacturer Narrative

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 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: 13481017
• MDR Text Key: 286374515
• Report Number: 2916596-2022-00440
• 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,Followup,Followup
• Report Date: 07/13/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 201-90052
• Device Catalogue Number: 201-90052
• Device Lot Number: L06049-LB2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 04/15/2022; 04/28/2022; 07/11/2022
• Supplement Dates FDA Received: 04/27/2022; 04/28/2022; 07/13/2022
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 5 KG