MAUDE Adverse Event Report: ABBOTT LABORATORIES / THORATEC CORP HEARTMATE 3 LVAS; VENTRICULAR (ASSIST) BYPASS

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Fungal Infection (2419)

Event Date 03/15/2023

Event Type  Injury  

Event Description

Patient with previous heartmate 3 lvad pump exchange on (b)(6) 2023 due to pseudomonas bacteremia.Admitted on (b)(6) 2023 as blood culture drawn on (b)(6) 2023 was positive for candida albicans.Id consulted who felt the picc was contaminated so picc was removed.Iv antibiotics changed to oral at time of discharge on (b)(6) 2023.Admitted on (b)(6) 2023 due to pseudomonas bacteremia.Iv antibiotics administered.Decision was made to perform another heartmate 3 lvad pump exchange as the apical sewing ring and part of the aortic graft was left in place with the last exchange.The patient was taken to the operating room on (b)(6) 2023 for a heartmate 3 lvad pump exchange, all aspects of the pump were exchanged.The surgeon noted no obvious purulence or vegetation.Surgery went well.The patient is currently recovering on the telemetry unit.Bloods cultures sent on (b)(6) 2023 and (b)(6) 2023 positive for strep mitis.Blood culture sent on (b)(6) 2023 positive for actinomyes species.Iv antibiotics will continue until (b)(6) 2023 at which time id will make further recommendations.

• Brand Name: HEARTMATE 3 LVAS
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT LABORATORIES / THORATEC CORP
• MDR Report Key: 16707233
• MDR Text Key: 313064839
• Report Number: MW5116483
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American