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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 Problem Device Displays Incorrect Message (2591)
Patient Problems High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)
Event Date 02/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
Event Description
The customer reported that on (b)(6) 2016, the freedom driver exhibited fault alarms while the patient was sleeping.The customer also reported that the freedom driver's displayed a cardiac output (co) of 3.7 to 4.0 during the reported alarms.The customer also reported that the patient's co is typically above 6.0.The customer also reported that the patient was subsequently switched to the backup freedom driver.The customer also reported that the patient felt anxious and his systolic blood pressure (sbp) was in the 140's after the driver switch.The customer also reported that the patient's blood pressure and co normalized to around 6.0.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited fault alarms, 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 determined the root cause of the customer-reported fault alarm was a degraded pressure sensor (u22) on the main printed circuit board assembly (pcba).Syncardia has an open capa (corrective and preventive action) to address the issue of u22 pressure sensor failures.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with u22 pressure sensor failure events.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 on (b)(6) 2016, the freedom driver exhibited fault alarms while the patient was sleeping.The customer also reported that the freedom driver's displayed a cardiac output (co) of 3.7 to 4.0 during the reported alarms.The customer also reported that the patient's co is typically above 6.0.The customer also reported that the patient was subsequently switched to the backup freedom driver.The customer also reported that the patient felt anxious and his systolic blood pressure (sbp) was in the 140's after the driver switch.The customer also reported that the patient's blood pressure and co normalized to around 6.0.
 
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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 Key5498857
MDR Text Key40573804
Report Number3003761017-2016-00081
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 02/29/2016
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 Manufacturer03/07/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/29/2016
Initial Date FDA Received03/14/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2013
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 Age30 YR
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