MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90010

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

Patient Problems Death (1802); Hemolysis (1886); Thrombus (2101); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Multiple Organ Failure (3261); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/12/2020

Event Type  Death  

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 expired after 9 days of centrimag support.The cmag pump was explanted and thrombus was found.The pump speed was 2500 rpm, flow was 2.01 lpm.The patient was supported with ecmo 4 days prior to cmag use due to cardiogenic shock caused by coronary spasm on (b)(6) 2020.There was no alarm for the event.The cause of death was confirmed to be multiple organ failure due to cardiogenic shock caused by coronary spasm.The patient's legs were cold, there was thrombus in the patient's aortic root and iliac artery.There was thrombus in the left artery and aortic root under transesophageal echocardiogram (tee) during cmag implanting.The thrombus was removed from the insert site of ecmo but not removed from the right artery and aortic root.Ldh was around 1200 on (b)(6) 2020 and increased to 2700 the day before the patient expired.Appt was kept at around 40-50 seconds.

Manufacturer Narrative

Section e: this event occurred at (b)(6) hospital in (b)(6), taiwan.Manufacturer's investigation conclusion: the evaluation of the returned centrimag blood pump, lot number l06436-la5, confirmed the report of device thrombosis.Additionally, a direct correlation between the device and the reported events leading to the patient's outcome could not be conclusively determined through this investigation; it was reported by the center that the patient's death due to multi organ failure was a result of cardiogenic shock prior to centrimag implant.The centrimag blood pump was returned without the circuit tubing or cannulas.A thrombus formation was observed between the rotor blades.The thrombus was not adhered to the rotor, suggesting that it did not initially form on the rotor and was likely ingested into the pump.The evaluation could not conclusively determine a specific cause for the development of the observed thrombus formation, its origin, or a duration of time for which it was present in the blood pump; however, the thrombus would have contributed to the report of elevated lactate dehydrogenase (ldh).Examination of the remaining blood-contacting surfaces of the returned blood pump revealed no evidence of any additional depositions or thrombus formations.Visual inspection of the pump¿s inlet and outlet ports, as well as the pump housing showed no evidence of damage.Following cleaning, microscopic inspection of the rotor and remaining blood-contacting surfaces revealed no anomalies.The blood pump was functionally tested on a mock circulatory loop and functioned as intended in accordance with manufacturing specification.The ous centrimag blood pump ifu contains the following information: the ifu contains the following warnings and precautions: ifu warning #15: 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 #17: frequent patient and device monitoring is recommended.Ifu warning #18: do not operate the pump in the absence of flow.The temperature within the pump will rise and increased cellular damage and clotting may result.Ifu warning #22: if centrimag vad operation is ever halted, consideration should be given to monitoring and adjustment of the patient¿s anticoagulation status.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #10: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #14: always have a spare centrimag blood pump, back-up console, and equipment available for change out.Review of the device history record (dhr) for the centrimag blood pump (dhr cm pump l06436-la5) revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS
• 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: 10520553
• MDR Text Key: 206505014
• Report Number: 3003306248-2020-00076
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2022
• Device Model Number: 201-90010
• Device Lot Number: L06436-LA5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECMO SUPPORT (MAQUET ROTAFLOW); ECMO SUPPORT (MAQUET ROTAFLOW)
• Patient Outcome(s): Death; Hospitalization