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 Death (1802); Blood Loss (2597)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

This event is also reported against the lvad pump under mfr # 2916596-2019-04867.Device serial and lot number information was requested from the customer but this information was not provided.Manufacturer's investigation conclusion: a direct correlation between the centrimag blood pump and the reported event could not conclusively be established through this evaluation.Additionally, the reported low flows could not be confirmed.It was reported that the patient expired.Per the information provided, the patient was very sick who had a lvad at the time of their cmems implant.It was felt the lvad wasn¿t functioning exactly and log files were sent in.The patient was admitted after a right heart catheterization and a cardiomems was implanted.The patient then had a gi bleed and 6-8 hours after an endoscopy they dropped pressure and had an rvad implanted.The patient could not be weaned off the rvad and the patient got sicker.The patient had an anal fissure that they kept bleeding from and needed to hold anticoagulation.The patient was too sick to bring to the or for a pump exchange.The patient¿s rvad and lvad had clots and low flows so the family decided to make the patient dnr.The patient then ultimately expired.The centrimag blood pump has not been returned to date.The centrimag blood pump ifu lists death and thromboembolism as adverse events that may be associated with the use on the centrimag vad.This document also warns the user to monitor the circuit carefully for any signs of occlusion.Additionally, this ifu explains that the pump is intended to be used with systemic anticoagulation and instructs the user to always have a spare centrimag blood pump, back-up console, and equipment available for change out.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was admitted after a right heart catheterization and a cardiomems implantation.The patient then had a gastrointestinal bleed and hours after her endoscopy she dropped her pressure and had an right ventricular assist device (rvad) implanted.The patient couldn't be weaned off the rvad and she got sicker.The patient had an anal fissure that kept bleeding and anticoagulation needed to be held.Due to the bleeding fissure, and rvad with clots the family decided to make her a do not resuscitate (dnr), shortly after the patient expired.The rvad device was confirmed to be an abbott centrimag device.

• 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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 9511306
• MDR Text Key: 176955296
• Report Number: 2916596-2019-06027
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 69 YR
• Patient Weight: 82