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 Hematoma (1884); Unspecified Infection (1930); Sepsis (2067)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

Serial number of pump was requested but not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient initially presented with cardiogenic shock that required ecmo (extracorporeal membrane oxygenation).The patient had a heartmate 3 implanted on (b)(6) 2020 and the rvad (right ventricular assist device) centrimag explanted on (b)(6) 2020.The patient had a prolonged hospital course complicated by ventilator-dependent respiratory failure status post tracheostomy on (b)(6) 2020.The patient had clostridium difficile right groin hematoma status post washout and sartorius flap on (b)(6) 2020.The patient was transferred back to the critical care unit (ccu) on (b)(6) 2020 due to altered mental status with concern for sepsis.The patient had sacral decubitus ulcers status post diverting loop sigmoid colostomy, gastrostomy-jejunostomy (gj) tube, and profound lower extremity weakness likely due to spinal infarct status (b)(6)2020.The patient had anuric renal failure on intermittent hemodialysis (ihd) and septic shock due to proteus bacteremia/(b)(6)/coagulase-(b)(6) (b)(6) on (b)(6) 2020.The patient had many episodes of bacteremia throughout hospitalization, one source was right groin clostridium difficile pneumonia.It was not known if it was device related.The treatment was iv (intravenous) antibiotics and wash-outs with irrigations/debridement.The patient had a hemorrhagic shock in the status post gastrointestinal bleeding that was complicated by acute hypoxemic/hypercarbic respiratory failure post tracheostomy exchange on (b)(6) 2020.The patient had ventilator-associated pneumonia post antibiotics and was transferred back to cardiac intensive care unit (cicu).Manufacturer report number of heartmate pump: 2916596-2021-00079.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the reported events and the centrimag device, (b)(6), could not be determined through this evaluation.Additionally, a specific cause for the reported infection could not be determined.It was reported under mfr # 2916596-2020-06542 that the centrimag blood pump was explanted on (b)(6) 2020.Multiple requests for additional information, including the disposition/return status of the device, were sent to the customer; however, no response has been received at this time.The us centrimag blood instructions for use (ifu) lists bleeding and infection as adverse events that may be associated with the centrimag circulatory support system.Review of the device history record (dhr) for the centrimag blood pump (dhr cm pump (b)(6)) revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) lists bleeding and infection as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.This ifu also provides the following 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 #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.

• 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: 11179807
• MDR Text Key: 229155759
• Report Number: 3003306248-2021-00007
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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 Expiration Date: 06/30/2021
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L05792-LA1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE 3 LVAS IMPLANT KIT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 101