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U.S. Department of Health and Human Services

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

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ABBOTT / THORATEC CORP. ABBOTT HEARTMATE 2 VENTRICULAR (ASSIST) BYPASS Back to Search Results
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).
 
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Brand NameABBOTT HEARTMATE 2
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
ABBOTT / THORATEC CORP.
MDR Report Key13847087
MDR Text Key287691309
Report NumberMW5108376
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received03/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/21/2022 Patient Sequence Number: 1
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