MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	102957
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Shock (2072); Respiratory Acidosis (2482); Bacteremia (4846); Hemodynamic instability (4868)
Date of Event	12/18/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away from shock.It was noted that the products had the possibility to be contaminated with methicillin-susceptible staphylococcus aureus.Related manufacturer reference number: 3003752502-2023-02412 (oxygenator) related manufacturer reference number: 3003306248-2023-08404 (centrimag console) related manufacturer reference number: 3003306248-2023-08405 (centrimag motor).
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a specific cause for the reported infection could not be conclusively determined.Additionally, a direct correlation between the centrimag blood pump and the reported events and patient outcome could not be determined through this evaluation.The centrimag blood pump instructions for use (ifu) lists infection as an adverse event that may be associated with the centrimag circulatory support system.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The centrimag blood pump instructions for use (ifu) lists infection and death as adverse events that may be associated with the centrimag circulatory support system.This ifu also provides the following warnings and cautions: ifu warming #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
The patient was cannulated for venous-venous extracorporeal membrane oxygenation (vv ecmo) and went on extracorporeal membrane oxygenation (ecmo) at 1802 and gradually started to lose flow over the next 30 minutes.A reason for the loss of flow had not been identified and log files were not available.Oxygenator inlet and outlet pressures were not available as they were not monitored and a copy of the gas analysis with values of pre- and post- oxygenator saturation was also not available.The patient was noted that the patient had an infection at the time of the event.Methicillin-susceptible staphylococcus aureus was identified, and the source of the infection was noted to be bacteremia.The infection was treated with antibiotics.An emergent oxygenator change was required, and the circuit was switched to the cardiohelp at 1844.At 2017, their partial thromboplastin time (ptt) was 76.6 seconds.A repeat echocardiogram showed worsening bi-ventricular function, so the patient was placed on venoarterial-venous extracorporeal membrane oxygenation (va-v ecmo).The patient's bilateral lower extremities (ble) were mottled, and they were taken to the catheterization lab for angiogram of ble and vascular consult.There was a concern that there was severe spasm of distal vessels.During the case, the patient became hemodynamically unstable again and developed metabolic acidosis.They were taken back to the intensive care unit (icu) and became severely vasoplegic and were unable to maintain mean arterial pressure or ecmo flow.The death was not considered to be device related.

• Brand Name: CENTRIMAG BLOOD PUMP
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18456650
• Report Number: 3003306248-2023-08406
• Device Sequence Number: 3167046
• Product Code: DWA
• UDI-Device Identifier: 07640135140139
• UDI-Public: 07640135140139
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K020271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 102957
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 182 KG