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

Model Number 102953

Device Problems Pumping Stopped (1503); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Death (1802); Unspecified Infection (1930); Thrombus (2101)

Event Date 02/26/2020

Event Type  Death  

Manufacturer Narrative

Serial number has been requested but not yet provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

Related manufacturer report number: 2916596-2020-01180.It was reported that the patient expired on (b)(6) 2020.The patient had decided to undergo left ventricular assist device (lvad) pump exchange and aortic valve replacement (avr) for treatment of her driveline fault.A redo sternotomy was performed and during device explantation, purulent drainage accidentally entered the chest cavity.A new lvad was not implanted and patient was transitioned to extracorporeal membrane oxygenation (ecmo) using centrimag circulatory support system until the infection could be cleared.At this point the patient was experiencing disseminated intravascular coagulation (dic) and the ecmo flow began to drop.A blood clot was found to have developed in the left ventricle and left atrium.Despite cleaning up the clot and altering cannulation strategies for ecmo, flow level remained low to none and clot continued to form in the left ventricle.The patient's mean arterial pressure was unable to be elevated above 30 mm hg.Her family ultimately decided to withdraw support.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported clot in the left ventricle/left atrium and patient expiration could not be determined through this evaluation.Moreover, the report of reduced flows could not be confirmed through this evaluation as no centrimag console log file data is available for review.A specific cause for the reported flow issue could not be conclusively determined.It was reported that during an attempted pump exchange on (b)(6)2020 due to suspected driveline damage, an area of infectious purulent drainage adhered to the ventricular apex was punctured and entered the chest cavity.Due to this, the heartmate ii pump was explanted and a new lvad was not placed.The left ventricle core was plugged and the patient was transitioned to extracorporeal membrane oxygenation (ecmo) using a centrimag system.At this point, the patient was in disseminated intravascular coagulation (dic) and ecmo flows began to drop.A clot was found to have developed in the left ventricle and left atrium despite an elevated activated clotting time (act) and initially good flows.Despite cleaning up the clot and altering cannulation strategies for the ecmo system, flow remained low to none with clot continuing to form in the left ventricle.The patient¿s mean arterial pressure (map) was unable to be elevated above 30 mmhg.Support was withdrawn and the patient reportedly expired due to sepsis on (b)(6)2020.Multiple attempts were made to obtain additional information from the customer regarding the lot number of the centrimag blood pump and whether the device would be returned; however, the requested information was not provided and the blood pump has not been returned to date.The centrimag blood pump instructions for use (ifu) lists embolic phenomena as a possible side effect that may be associated with the use of the device.The centrimag ventricular assist system (vas): patient & device management guidelines and the patient and family information for the centrimag ventricular assist system (vas), list death as a potential complication that may be associated with the use of the centrimag.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: 10165138
• MDR Text Key: 195474154
• Report Number: 3003306248-2020-00051
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• 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: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 70