MAUDE Adverse Event Report: MEDTRONIC INC. MEDTRONIC HEARTWARE; VENTRICULAR (ASSIST) BYPASS

Device Problems Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/21/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 low flow alarms with flows 0.4-0.8 l/min on hvad.Transferred back to cticu for suspected inflow cannula thrombus, stable on milrinone and bivalirudin gtt.Underwent hvad to hm3 exchange on (b)(6) 2022, pt tolerated well and discharged home (b)(6) 2022.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC HEARTWARE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC INC.; minneapolis MN 55432
• MDR Report Key: 14787629
• MDR Text Key: 294663669
• Report Number: MW5110450
• 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 Practitioner
• Type of Report: Initial
• Report Date: 06/17/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American