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

Model Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Hemolysis (1886); Hemorrhage/Bleeding (1888); Tachycardia (2095)

Event Date 04/27/2021

Event Type  Injury  

Event Description

It was reported that the patient had cardiac arrhythmia after blood pump was implanted on (b)(6) 2021.Amiodarone and magnesium was administered on (b)(6) 2021 for atrial fibrillation and ventricular tachycardia which returned the patient to normal sinus rhythm with continued tachycardia/fibrillation runs following.Baseline digoxin was started (b)(6) 2021 and atrial fibrillation was ongoing the next day with amiodarone dops started.On (b)(6) 2021 , the patient was noted to be tearful, confused, and agitated which require seroquel psychosocial management.Medications were optimized on (b)(6) 2021 for psychiatric episode.The patient was given 1 unit of red blood cells on (b)(6) 2021 for hemoglobin management keeping it above 7.5.No source of bleeding was noted.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported cardiac arrhythmias, psychiatric episode and bleeding episodes, as well as a direct correlation to the centrimag blood pump could not conclusively be determined from this evaluation.Per additional information from the biomedical engineer, the centrimag blood pump is no longer in use.The pump will not be returned as the patient was taken off support approximately 3 months ago.The patient is no longer supported by centrimag blood pump lot number l00000-13.No product is available for investigation.The device history records for centrimag blood pump lot number l00000-13 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump us instructions for use lists bleeding, cardiac arrhythmias and psychiatric episode as adverse events that may be associated with the use of the centrimag circulatory support system.Warning 7: it is intended that systemic anticoagulation be utilized while the device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Warning 10: frequent patient and device monitoring is recommended.Warning 15: a backup centrimag pump, console, motor and accessories should be available for use.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: 11865711
• MDR Text Key: 253821019
• Report Number: 3003306248-2021-01112
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L0000013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 69