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

Model Number 102953

Device Problem Mechanical Problem (1384)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/26/2020

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

Related manufacturer report number: 2916596-2020-04403 it was reported through patient outcome that the patient expired due cardiogenic shock and septic shock.There was a small mobile thrombus on rvad inflow cannula.The rvad was confirmed to be a centrimag rvad with oxygenator.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

It was reported that the oxygenator used in this event was from a different manufacturer.

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.It was reported that on (b)(6) 2020, a transesophageal echocardiogram (tee) was performed and showed severe biventricular dysfunction with no evidence of right atrium or right ventricle clot; however, a small mobile thrombus was noted in the right ventricular assist device (rvad) inflow cannula.The rvad speed was increased to 3800 rpm, with flow of 4.5 lpm.On (b)(6) 2020, the patient's condition worsened with multiple comorbidities; the rvad speed was increased and there was chugging of the rvad noted.On (b)(6) 2020, the patient transitioned to comfort care and died with family present at the bedside.The patient was in no distress.The death was not considered to be device-related.The device operated as expected.The device will not be returned for evaluation.The centrimag blood pump ifu (rev.09) lists thromboembolic phenomena as a possible side effect that may be associated with the use of the centrimag blood pump (ifu warning #3).The ifu contains the following additional warnings and precautions: 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 warming #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 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 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 (b)(6) ) 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
• 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: 11508040
• MDR Text Key: 251187623
• Report Number: 3003306248-2021-01075
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2021

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: 04/30/2022
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L06432-LA8
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 04/19/2021; 06/17/2021
• Supplement Dates FDA Received: 05/18/2021; 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR
• Patient Weight: 101