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); Sepsis (2067); Thromboembolism (2654)

Event Date 02/25/2020

Event Type  Death  

Manufacturer Narrative

The outflow graft infection was reported under mfr 2916596-2020-01306.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient developed a large abscess in his mediastinum around his outflow graft that had traveled through the abdominal muscle to the substernal tissue.The patient originally presented with a fever and had positive cultured on (b)(6) 2020.The culture was staph aureus.The patient developed chest pain on (b)(6) 2020 and a ct (computerized tomography) scan was performed and found a fluid collection around the outflow graft.Despite antibiotics the patient continued to be febrile and his status declined.On (b)(6) 2020 the patient's infection had tunneled through the abdominal muscle and was a visible pulsatile abscess below his sternum.The patient was taken to the operating room on (b)(6) 2020 to drain the abscess.An echo and ultra sound was performed.The hm3 (heartmate 3) was removed and the patient was placed on ecmo (extracorporeal membrane oxygenation).The patient was upgraded on unos list status for an urgent heart transplant.The hm3 outflow graft was successfully removed and ecmo was initiated.It was suspected that the patient went into dic (disseminated intravascular coagulation) from sepsis as the patient quickly clotted off both the ecmo circuit and the cardiopulmonary bypass circuit despite it being reported that the patient was adequately anticoagulated.The patient had no pressure at this time and nothing further could be done.Time of death was pronounced and the patient died on (b)(6) 2020.The death was not considered to be device related.The patient had no history of infections or operations post implant.It was unclear how the patient developed the abscess.The source could no be identified.The death was reported to be due to dic (disseminated intravascular coagulation).

Manufacturer Narrative

Section d4, h4: additional information.Section g9: the initial report was sent with an incorrect first mfr number (2916596).The correct number is 3003306248.Manufacturer's investigation conclusion: the device history record (dhr cm pump l05811-la6) was reviewed and showed that the device was manufactured in accordance with manufacturing and quality assurance specifications.The report that the ecmo circuit utilizing the centrimag system clotted off could not be confirmed through this evaluation because the centrimag blood pump, lot number l05811-la6, was not saved following the patient¿s expiration and no photographs showing the presence of device thrombosis were submitted for review.A direct correlation between the device and the reported patient outcome could not be determined through this evaluation.The centrimag blood pump ifu lists thromboembolic phenomena as a possible side effect that may be associated with the use of the device.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: 9836940
• MDR Text Key: 183609940
• Report Number: 2916596-2020-01463
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 102953
• Device Lot Number: L05811-LA6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 88