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 Hemorrhage/Bleeding (1888); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2021

Event Type  Death  

Event Description

It was reported that the patient developed a klebsiella pneumonia infection; this was discovered through a mini-bronchoalveolar lavage (mini-bal) culture.The patient was given 100 mg of intravenous micafungin antibiotics as well as intravenous vancomycin.The patient was transplanted on (b)(6) 2021 and experienced coagulopathy; the chest was left open with an esmarch dam.The patient returned to the er that same day and had the dam removed and a clot in their chest removed.There was no active bleeding but the patient was still coagulopathic; the sternum was left open but the skin was closed and a chest tube was placed.The patient was given several rounds of blood transfusions from (b)(6) 2021 to (b)(6) 2021.Blood tests were also performed from (b)(6) 2021 to (b)(6) 2021.A centrimag was implanted on (b)(6) 2021 for right ventricular (rv) support; the patient was also given epinephrine, norepinephrine and dobutamine inotropic support.Extracorporeal membrane oxygenation (ecmo) was also started on (b)(6) 2021 as the patient was noted to have airway bleeding; a bronchoscopy was performed for aspiration of clots.Two subsequent bronchoscopies were performed on (b)(6) 2021 and (b)(6) 2021 for airway breathing and right upper lobe (rul) blood clot removal, respectively.No active bleeding was seen as of (b)(6) 2021.The patient also begun continuous renal replacement therapy (crrt) for renal dysfunction starting on (b)(6) 2021.On (b)(6) 2021 an infection was suspected in the patient's old ventricular assist device (vad) driveline; the patient was taken to the or for complete debridement of the driveline tract and placement of a right chest tube.Ciprocloxin, doxycycline, meropenem and tobramycin were administered intravenously.An intra-aortic balloon pump was placed in the patient for their right heart failure on (b)(6) 2021 and removed on (b)(6) 2021.An oxygenator was added to the right ventricular assist device (rvad) on (b)(6) 2021.The patient's pneumonia seemed to improve on (b)(6) 2021.The patient's family eventually requested removal of care, and the patient soon expired on (b)(6) 2021.Related mfr # 2916596-2021-06602.

Manufacturer Narrative

The centrimag blood pump lot number is unknown as the site does not have this information.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

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

Event Description

Additional information: the centrimag was removed on (b)(6) 2021 and replaced with a right ventricular assist device (rvad; this was not an abbott product.The patient was weaned off their ventilator on (b)(6) 2021 but was reintubated on (b)(6) 2021.A tracheostomy was performed on (b)(6) 2021, and the patient remained intubated.New cultures were drawn on (b)(6) that were positive for a fungal infection; vancomycin and meropenam were resumed.On (b)(6) 2021, the patient experienced cardiogenic shock due to sepsis; ecmo was initiated, and they were given intravenous dobutamine and angiotensin ii.The patient remained unresponsive and was continued on vasopressor support as well as crrt.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events as well as a direct correlation to the centrimag blood pump could not conclusively be determined through this evaluation.The centrimag blood pump lot number that was provided was incorrect and the customer was unable to provide a lot number.The centrimag blood pump was not returned for evaluation.The centrimag blood pump instructions for use (ifu) is currently available.This ifu lists bleeding, respiratory failure, infection, and renal dysfunction as adverse events that may be associated with the use of the centrimag blood pump.The ifu provides the following warning: 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.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: 12807454
• MDR Text Key: 280739107
• Report Number: 3003306248-2021-05711
• 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: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2022

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
• Device Operator: Health Professional
• Device Model Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 11/14/2021; 01/13/2022
• Supplement Dates FDA Received: 12/09/2021; 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Death; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 124 KG