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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. HEARTWARE HVAD SYSTEM; VENTRICULAR (ASSIST) BYPASS
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MEDTRONIC, INC. HEARTWARE HVAD SYSTEM; VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 1103
Device Problems Device Alarm System (1012); Pumping Stopped (1503); Patient Device Interaction Problem (4001)
Patient Problem Failure of Implant (1924)
Event Date 03/10/2022
Event Type  Death  
Event Description
Patient accidentally unplugged unit from power and ventricular assist device (vad) stopped alarm requiring a controller exchange.Patient was advised to change controller.The controller exchange was done successfully, however the pump did not restart.Patient was asked to look at the controller and the rpms would go from 0 up to 500 and back down to 0 and after multiple attempts to start the "vad stopped alarm change controller alarm.".
 
Event Description
Patient accidentally unplugged unit from power and ventricular assist device (vad) stopped alarm requiring a controller exchange.Patient was advised to change controller.The controller exchange was done successfully, however the pump did not restart.Patient was asked to look at the controller and the rpms would go from 0 up to 500 and back down to 0 and after multiple attempts to start the "vad stopped alarm change controller alarm." notes from clinical team in response to medical device failure below.Patient called our vad emergency line with a "vad stopped alarm requiring a controller exchange." patient was advised to change controller.This was done successfully however the pump did not restart.Patient was asked to look at the controller and the rpms would go from 0 up to 500 and back down to 0 and after multiple attempts to start the "vad stopped alarm change controller alarm." patient was advised to call 911.Healthcare provider spoke to paramedics via the phone.Iv started.Patient in st rhythm and speaking full sentences and not diaphoretic.They were advised to have epi drip and epi ivp available in case level of consciousness (loc) reduces and be transported immediately to emergency room for an emergent pump exchange."lvad stopped.Patient was attached to our tablet.Lvad was at 0 flow and 0rpms.Lvad was stopped on the tablet and restarted and rpms would increased up to 280 and 300 and then turn to 0 rpms and cycle thru this after multiple restarts.Lvad would not restart.Doctor was notified and patient to have emergent lvad pump exchange.Risks and benefits were explained to the patient and mother at the beside and consent signed and they agreed to proceed.Questions and concerns addressed.When patient was asked what events lead up to the ¿vad stopped¿ alarm.The patient stated he was in his car with his mom and sister.His controller had a battery attached as a power source and he had his second power source as the dc adapter in his car.He had just turned his car off therefore the second power source with the dc adapter was no longer powering his controller.His vad was being powered by the one battery attached to the controller.Then, he accidently disconnected the battery powering his controller which interrupted power to the controller briefly.He immediately attached the battery to the controller to reestablish power to the controller and he received the ¿vad stopped, change controller¿ alarm and proceeded to call our vad emergency line immediately.
 
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Brand Name
HEARTWARE HVAD SYSTEM
Type of Device
VENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key14415714
MDR Text Key291819793
Report Number14415714
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/26/2022
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? No
Device Model Number1103
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/26/2022
Device Age22 MO
Date Report to Manufacturer05/17/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/17/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/27/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age14235 DA
Patient SexMale
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