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

Model Number 102953

Device Problem Infusion or Flow Problem (2964)

Patient Problems Right Ventricular Failure (2055); Blood Loss (2597); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

During the pump exchange there was substantial bleeding and the right heart was struggling; therefore, a centrimag rvad was placed.Once bleeding was under control, the patient left the or with exchanged hm3, centrimag rvad, iabp (placed prior to return to or), and chest was left open.It is suspected that the patient has developed a coagulation problem, likely heparin-induced thrombocytopenia.They stopped using heparin and used bivalirudin to anticoagulate while on bypass for the hm3 exchange.The patient had cultures taken and were positive for candida albicans.The patient was also septic.In the pre-operative diagnosis the patient had heparin induced thrombocytopenia thrombosis.The findings post-operatively included right ventricular dysfunction.On (b)(6) 2020 the patient was going back to the operating room for class a emergency with a concern for bleeding.The patient had evolving bacteremia and fungemia.On (b)(6) 2020 the patient continued to have low flow alarms.Additionally, there was a concern that the centrimag rvad not filling the lvad appropriately.On (b)(6) 2020 the patient was in cardiogenic and septic shock.The patient continued to decline.The patient went into multi-system organ failure on (b)(6) 2020.The family withdrew care and the patient passed away on (b)(6) 2020.The pump is reported under mfr #2916596-2020-06011.

Manufacturer Narrative

Section b2: death was inadvertently selected in the previous report.The patient death is reported under related manufacturer report number: 2916596-2021-00934.Manufacturer's investigation conclusion: a specific cause for the reported event, as well as a direct correlation to the centrimag device, could not be determined through this evaluation.It was reported that the patient¿s right heart was struggling during a pump exchange and required centrimag right ventricular assist device (rvad) placement.The patient then had low flow alarms on his left ventricular assist device (lvad).A transesophageal echocardiogram (tee) revealed a dilated right ventricle with an empty left ventricle.Inotropes and epinephrine caused the left ventricular cavity to fill and lvad flows increased.However, there was concern that the rvad was not filling the left ventricle appropriately.It was recommended to turn down the rvad flow and give more fluid and blood to the patient.Later, the patient went to the operating room (or) for a chest washout and the inflow cannula in the patient¿s left groin was found to be sucked down on his rvad.The rvad speed was reduced and the patient was given blood and crystalloid which improved suction.As of the date of this report, centrimag blood pump, lot number unknown, has not been received and the file will be closed accordingly.The customer was unable to provide the lot number of the centrimag blood pump and the device history record (dhr) could not be reviewed.The centrimag blood pump instructions for use (ifu) contains the following warnings and cautions: ifu warning #10: frequent patient and device monitoring is recommended.Ifu warning #12: do not operate the pump in the absence of forward flow.The temperature within the pump will rise and increased cellular damage and clotting may result.Ifu warning #15: monitor the patient¿s hemodynamics and the console flow display to ensure adequate blood volume for the inlet cannula position, pump rpm, and desired flow.Increase the pump rpm in small increments to minimize the risk of exceeding the available blood volume and causing inlet cannula obstruction, suction, outgassing, and/or cavitation.Ifu warning #16: as with all continuous flow pumps, operating at too high a speed can result in negative pressure at the inlet which can lead to collapse of the ventricle or blood vessels, inlet cannula obstruction, inspiration of air, outgassing, cavitation and increased risk of embolism.Always operate the system at the lowest speed consistent with the volume of blood available to be pumped and clinically acceptable circulatory support.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #6: attach tubing to the pump in such a manner as to prevent kinks or restrictions that may alter flow or cause regions of stasis or turbulence.Attach in a manner that does not bend or fracture the tubing connectors or ports.Advance the tubing beyond the second barb point of the pump connectors.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.Furthermore, the ifu states that, ¿actual obtainable flow is dependent on the difference between the preload and afterload of the pump (pump pressure differential, the resistance to flow through the extracorporeal circuit components (cannulas, tubing, etc.) and the patient hemodynamics (intravascular pressures, cardiac output, and available volume)¿ under ¿pressure vs flow graph¿.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." section 12.1 entitled "appendix i ¿ console alarms and alerts" in this ifu contains a list of console alarms and alerts, including f2 and f3 alarms, as well as appropriate operator response to these events.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: 11041508
• MDR Text Key: 222659167
• Report Number: 3003306248-2020-05468
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6)
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 61 YR
• Patient Weight: 89