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

Model Number 201-90015

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

Patient Problem Blood Loss (2597)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

Serial number was not provided therefore udi is not available.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer reference number: 2916596-2020-02325.It was reported that patient required temporary centrimag rvad support, which remained in place.There was an increased in chest tube drainage, hemoglobin drifted down, fevers, leukocytosis, negative site cultures, and negative blood cultures.The patient received packed red blood cell (prbcs) transfusions.Patient was taken back to operating room on (b)(6) 2020 for chest bleeding.Hemostasis was achieved.Patient is ongoing medical management.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the centrimag device and the reported post-operative chest bleeding, fevers, and leukocytosis could not be determined through this evaluation.No alarms or functional issues with the heartmate 3 lvas or centrimag rvas were reported in association with the event.At the time the event was reported on (b)(6) 2020, the patient was receiving ongoing medical management and remained ongoing on centrimag rvad support.The centrimag blood pump, lot number unknown, is not available for analysis.The patient remains ongoing on lvad support and no additional events have been reported at this time.The centrimag rvas blood pump ifu lists bleeding as a potential medical risk and a possible side effect associated with use of the centrimag vad.The centrimag blood pump ifu and the centrimag rvas blood pump ifu state that 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.These documents also caution to always have a spare centrimag blood pump, back-up console, and equipment available for change out.The centrimag rvas blood pump ifu lists bleeding as a potential medical risk associated with the use of the centrimag vad.This ifu also lists bleeding as a possible side effect of using the device.In addition, this document outlines the recommended anticoagulation guidelines for patients supported on the centrimag system.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP, US
• 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: 10038656
• MDR Text Key: 190503959
• Report Number: 2916596-2020-02481
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 201-90015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE 3 LVAS IMPLANT KIT.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 50