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 Problem Atrial Fibrillation (1729)

Event Date 04/24/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2021, patient experienced atrial fibrillation (a-fib) and was given three bolus of amiodarone 150 milligram and then started on amiodarone 1.0-0.5 mg/min with continuous iv (intravenous).The patient returned to normal sinus rhythm (nsr) on (b)(6) 2021.On (b)(6) 2021 patient experienced a-fib and was given a bolus of amiodarone and returned to nsr on (b)(6) 2021.Patient remained in nsr since (b)(6) 2021.Patient also had a-fib with rapid ventricular rate or response (rvr) noted.Patient was discharged on (b)(6) 2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported infection could not be conclusively determined.Additionally, a direct correlation between the reported events and the centrimag device could not be conclusively established through this evaluation.It was reported that the patient was experiencing atrial fibrillation and was treated with antiarrhythmic medication.The patient returned to normal sinus rhythm on (b)(6) 20221.A tracheal aspirate performed on (b)(6) 2021 revealed an infection that was treated with antibiotics.The infection resolved on (b)(6) 2021.In addition, the patient experienced intensive care unit (icu) delirium and refused to wear a nasal cannula or continuous pulse oximeter.The patient was treated with an antipsychotic medication and returned to baseline on (b)(6) 2021.The patient was discharged on (b)(6) 2021.Multiple attempts were made to obtain additional information from the customer regarding the centrimag pump return status; however, no additional information was provided.The centrimag device has not been returned for evaluation at this time.The us (united states) centrimag blood pump instructions for use (ifu) lists cardiac arrhythmia, infection, and psychiatric episode as adverse events that may be associated with the centrimag circulatory support system.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.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: 11890385
• MDR Text Key: 256543654
• Report Number: 2916596-2021-02751
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 74