MAUDE Adverse Event Report: ABBOTT LABORATORIES (FORMALLY SJM AND THORATEC) HEARTMATE II LVAS; VENTRICULAR (ASSIST) BYPASS

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2018

Event Type  Injury  

Event Description

Pt seen in clinic on (b)(6) 2018 during which the controller was noted to have multiple driveline fault alarm seen in the history.Waveforms and data were sent to abbott labs for evaluation.Their evaluation noted there was a driveline issue and recommended repair by splicing the driveline.The pt was admitted for monitoring.The abbott engineers repaired the driveline by spicing a new one on (b)(6) 2018.The controller history indicated continued driveline fault alarms after the repair.The decision was made to take the pt to the operating room on (b)(6) 2018 for a heartmate ii pump exchange.Surgery went well.The pt is currently recovering on our telemetry unit.

• Brand Name: HEARTMATE II LVAS
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT LABORATORIES (FORMALLY SJM AND THORATEC); pleasanton CA 94588
• MDR Report Key: 7525333
• MDR Text Key: 108673164
• Report Number: MW5077281
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• 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: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 59