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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)
Patient Problems High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)
Event Date 02/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
Event Description
The customer reported that the freedom driver exhibited fill volumes in the 30's.The customer also reported that the patient's blood pressure was slightly elevated during the reported issue.The customer also reported that the patient was subsequently switched to the backup freedom driver and his medication was adjusted.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited fill volumes in the 30's, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.Investigation testing did not reveal any indications of a malfunction of the electronics of the driver and the customer did not report any alarms.The driver passed all functional test requirements, which included testing at nominal normotensive and hypertensive settings, with no anomalies or alarms.The driver was also subjected to an additional 48 hour observation run at normotensive settings, followed by a 24 hour observation run at hypertensive settings in an attempt to duplicate the reported issue.The driver passed all additional testing with no anomalies or alarms.No issues were observed during testing and the customer-reported issue could not be duplicated, therefore a root cause could not be determined.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
Event Description
The customer reported that the freedom driver exhibited fill volumes in the 30's.The customer also reported that the patient's blood pressure was slightly elevated during the reported issue.The customer also reported that the patient was subsequently switched to the backup freedom driver and his medication was adjusted.There was no reported adverse patient impact.
 
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Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5451120
MDR Text Key39209391
Report Number3003761017-2016-00057
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 02/08/2016
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
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2016
Initial Date FDA Received02/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age28 YR
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