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

Model Number 102953

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Multiple Organ Failure (3261); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/15/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had multiple right ventricular assist device (rvad) placements, clotting, and kidney dysfunction.The kidney dysfunction was not device related.It was treated with continuous venovenous hemodiafiltration (cvvhd).The right heart failure developed after pump implantation.It was not device related.There were 2 rvad placements performed, one to wean off, and another due to right ventricular failure exacerbation.A thrombus was found in the pump of the rvad, so it was discontinued.The patient eventually passed away due to multisystem organ failure.The pump operated as expected and the outcome was not device or therapy related.Related lvad manufacturer report number: 2916596-2024-00686.

Event Description

It was reported that on (b)(6) 2023, the patient had their heartmate ii pump exchanged to a heartmate 3 pump, with right ventricular assist device (rvad) for support.It was noted that the patient was stable post exchange; however, additional information revealed that the patient had multiple rvad placements, clotting, and kidney dysfunction.The kidney dysfunction was reportedly not device related and was treated with continuous venovenous hemodiafiltration.The right heart failure developed after pump implantation; however, it was not thought to be device related.There were 2 rvad placements performed, one to wean off, and another due to right ventricular failure exacerbation.A thrombus was found in the pump of the rvad, so it was discontinued.The patient eventually passed away on (b)(6) 2024 due to multi-system organ failure.It was noted that the device operated as expected and the outcome was not considered device or therapy related.Related manufacturer report numbers: 2916596-2023-07443 and 2916596-2024-00686.

Manufacturer Narrative

Manufacturer's investigation conclusion: clotting was unable to be confirmed as the device was not returned for evaluation, and no photos were submitted.A direct correlation between the reported events and the centrimag blood pump could not be conclusively established through this evaluation.The centrimag blood pump was not returned for evaluation.The united states centrimag blood pump instructions for use (ifu) (rev.C) lists potential adverse events that may be associated with the use of the centrimag blood pump, including venous thromboembolism, arterial non-cns (non-central nervous system) thromboembolism, death, and multiple types of organ failure and dysfunction (hepatic dysfunction, renal failure/dysfunction, respiratory failure, and right heart failure).The ifu contains the following additional warnings and cautions: ifu warning #7: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #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 #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18687280
• MDR Text Key: 335193715
• Report Number: 3003306248-2024-00399
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 132 KG