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

Model Number 100170480

Device Problem Mechanical Problem (1384)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/11/2021

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 implanted with the centrimag lvad on (b)(6) 2021.The patient was cannulated centrally with no issues at the time.Over the weekend, the patient had a fibrin clot at the 3/8 quick connects.The quick connect for the inflow had a side port on it.Fibrin seemed to be more substantial at the port.Nothing was done at the time and allowed the device to continue running.The patient was explanted on (b)(6) 2021.Before the explant, the physician called for an echo of the heart for cannula placement.At this point, they noticed a large clot in the left ventricle (lv) moving around the tip of the cannula.They also are looking into seeing if this was a heparin-induced thrombocytopenia (hit) patient.The patient was taken back to the operating room (or) to replace lv cannula, remove the clot, and shorten tubing at the same time.They used the same pump initially implanted.The patient went to the intensive care unit (icu) fine.

Manufacturer Narrative

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 centrimag device could not be determined through this evaluation.The patient remains ongoing on centrimag blood pump, lot number: l06960-la4.No further issues have been reported at this time.The device history record (dhr) for the centrimag blood pump (dhr cm pump l06960-la4) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) thromboembolic phenomena as a possible side effect that may be associated with the use of the centrimag blood pump (ifu warning).This ifu also provides the following warnings and cautions: ifu warning: 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: frequent patient and device monitoring is recommended.Ifu warning: 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: 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: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution: always have a backup centrimag pump, console, motor, and accessories available for use.No further information provided.The manufacturer is closing the file on this event.

• 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
• MDR Report Key: 12319802
• MDR Text Key: 266847201
• Report Number: 3003306248-2021-02999
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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: 11/17/2023
• Device Model Number: 100170480
• Device Lot Number: L06960-LA4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 15 YR
• Patient Weight: 67