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

Model Number 102953

Device Problems Mechanical Problem (1384); No Apparent Adverse Event (3189)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

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

Related mfr 2916596-2023-08076.It was reported that the patient was high risk and that this was the patinet's fourth sternotomy.The patient had a history of aortic reconstruction after an extensive aortic aneurysm in the past, prior to the pump implantation, which extended down their iliac arteries.The patient also had a history of restrictive lung disease.A plan was made for a possible right ventricular assist device (rvad) or extracorporeal membrane oxygenation (ecmo) to get off cardiopulmonary bypass (cpb).There was talk of needing circulatory arrest and cardioplegia by the surgeon.The patient experienced a lot of bleeding during pump implantation due previous aortic dissection dehiscence.When the surgeon went to anastomose the outflow graft (ofg), the previous aortic graft repair dehisced and required an aortic repair/reconstruction with dacron graft.Eventually, the ofg was attached and the pump was run at 3000rpm and slowly incremeted up to 5400rpm, flow 3.4 liters per minute (lpm), pulsatility index (pi) 4.7, and pump power 3.5 watts.The hemodynamics were stable at that time; however, the patient continued oozing blood from multiple areas, not at the pump or the apical cuff ring.The patient was placed on ecmo.This was all in conjunction with the bypass oxygenator clotting and needed to switch out the filter.When they swapped it out the blood pressure and hemodynamics tanked, and anesthesia couldn't keep up.The pump flow was 0.5 lpm.The pump was turned down while trying to get hemodynamics and volume back up.The cpb was down for about a minute and they had it running again.They used two cell savers to return the blood, and ordered a massive transfusion protocol in which multiple products were given rapidly.They also gave multiple bags of fresh frozen plasma and ffp and kcentra (prothrombin complex concentrate).They were actively coding the patient with drugs etc.Shortly thereafter all supportive lines (bypass cannulas, ecmo cannulas, cell savers, and the heart itself) were all clotted.The patient expired at 9:53pm.

Manufacturer Narrative

Manufacturer's investigation conclusion: it was reported that the patient experienced clotting in an extracorporeal membrane oxygenation (ecmo) circuit; however, the manufacturer of the oxygenator and extracorporeal pump involved is unknown.Multiple attempts were made to obtain additional information from the customer regarding the event, including the manufacturer and lot numbers of the products involved; however, no additional information was provided.Although it was not confirmed a centrimag pump was in use during the reported event, the centrimag blood pump ifu, rev.B, lists bleeding, thromboembolism, and death as adverse events that may be associated with the use of the centrimag circulatory support system.The ifu contains the following additional warnings and precautions: 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 warming #10: frequent patient and device monitoring is recommended.Ifu warning #19: do not restart the pump if the pump has been stopped for more than 5 minutes without adequate anticoagulation, as the risk of thromboembolism is increased after blood has remained stagnant in the pump, extracorporeal circuit, connectors, and cannulae.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 spare centrimag blood pump, back-up console, and equipment available for change out.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: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 18192159
• MDR Text Key: 328806387
• Report Number: 3003306248-2023-07189
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/08/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White