MAUDE Adverse Event Report: ABBOTT / THORATEC CORPORATION HEARTMATE SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Device Problems Connection Problem (2900); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2021

Event Type  Injury  

Event Description

Pt seen in clinic for assessment of continued "power cable disconnect" alarms on his lvad.The event log captured some power cable disconnect events on (b)(6) 2021 at 0815-0817 occurring on the black power lead while using the mpu.Appears there may have been an intermittent connection between the power lead and the pt cable.Fda safety report id # (b)(4).

• Brand Name: HEARTMATE SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT / THORATEC CORPORATION
• MDR Report Key: 12569095
• MDR Text Key: 274776913
• Report Number: MW5104351
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 77