MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG; CENTRIMAG BLOOD PUMP

Catalog Number 201-90010

Device Problem Air Leak (1008)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 07/15/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ (b)(4).The event occurred at (b)(6).It was reported that no devices would be returned for evaluation.Additional information was requested but not provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the patient experienced right heart failure and required placement of a right ventricular extracorporeal life support (ecls) device on (b)(6) 2017.Post-operatively the patient improved and was able to be weaned off inotropes and was cycling between continuous positive airway pressure (cpap) and synchronized intermittent-mandatory ventilation (simv) in preparation for extubation.On (b)(6) 2017, there was a sudden decrease in lvad flow, and the patient¿s blood pressure dropped from a mean of 80 mmhg to 30 mmhg over a period of about 10 minutes.A unit of iv gelafundin was started.The lvad and the right heart ecls devices both sounded low flow alarms.The patient then suddenly became asystolic despite vvi pacing with the output at maximum.The patient¿s blood pressure and pump flows had been normal the whole day up until this event.The patient became unresponsive and no lvad flow was observed.Resuscitation with cpr commenced and the ventilator oxygen was increased to 100%.It was reported that approximately one-third of the ecls pump chamber was foamy with air.It was not known if the ecls pump was spinning at the time.The customer reported that the venous cannula was still in place and all the connections were still tight.The clinicians reported that the air could have come from the central venous line when the gelafundin was being infused.Despite resuscitation efforts, there was no spontaneous return of rhythm, pulse or breathing, and the pupils were fixed and dilated.Cpr was stopped and the patient expired.No additional information was provided.

Manufacturer Narrative

A specific root cause for the reported patient expiration could not be conclusively determined.A correlation between the device and reported event was not determined as the device was not returned for analysis.It was reported that both lvad and rvad devices were working as expected; the pump was running even as the patient became asystolic.The pump was only stopped when the medical treatment was deemed futile.A review of the device history records found no deviations from manufacturing specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG
• Type of Device: CENTRIMAG BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 6809315
• MDR Text Key: 83190656
• Report Number: 2916596-2017-01849
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 201-90010
• Device Lot Number: L04395-LA01
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 38