MAUDE Adverse Event Report: ABBOTT / THORATEC CORP. ABBOTT HEARTMATE 2; VENTRICULAR (ASSIST) BYPASS

Device Problems Display or Visual Feedback Problem (1184); Pumping Stopped (1503); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  Injury  

Event Description

Pt phoned lvad team with c/o "low flow alarms" and "my pump stopping".Pt brought into ed where it was noticed upon device interrogation that his lvad was experiencing pump stoppage with low flow alarms.This was happening, according to pt, mostly while he was on his mobile power unit (mpu) at home.Upon presentation to the ed, the pt's device was interrogated and a possible short to shield complication was found.Xrays of the drive line were obtained and sent to abbott for analysis.After log file analysis review from abbott, pt placed on ungrounded monitor cable and education provided to pt and ed staff the reasons for doing this.Education re: alarm and possible drive line fracture explained to pt and caregiver.Fda safety report id# (b)(4).

• Brand Name: ABBOTT HEARTMATE 2
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT / THORATEC CORP.
• MDR Report Key: 13847087
• MDR Text Key: 287691309
• Report Number: MW5108376
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White