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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. 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 06/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the patient had a constant fault alarm on the freedom driver while the patient's systolic blood pressure was in the high 150's.The customer also reported that the patient was brought into the clinic and assessed at which time the clinic staff was able to lower the patient's blood pressure.The customer also reported that the patient was subsequently switched to a companion 2 driver for further evaluation.The customer also reported that the patient was then switched to a backup freedom driver.There was no reported adverse patient impact during the driver changes.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, 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
(b)(4).
 
Event Description
The customer reported that the patient had a constant fault alarm on the freedom driver while the patient's systolic blood pressure was in the high 150's.The customer also reported that the patient was brought into the clinic and assessed at which time the clinic staff was able to lower the patient's blood pressure.The customer also reported that the patient was subsequently switched to a companion 2 driver for further evaluation.The customer also reported that the patient was then switched to a backup freedom driver.There was no reported adverse patient impact during the driver changes.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external and internal components revealed no anomalies.Review of the alarm history (eeprom) revealed one permanent fault alarm, which was recorded when the freedom driver was supporting the patient.This fault alarm can occur: - during power cycling of the freedom driver, which can take place at either the clinical site or prior to the eeprom reading during the failure investigation; - during onboard battery exchange while operating the freedom driver only on battery power; and - if an onboard battery is not fully latched in place, intermittent communication errors can result in a fault alarm.During the investigation, the freedom driver was tested and passed all test acceptance criteria, which included normotensive and hypertensive patient simulator settings, with no anomalies or alarms.The reported fault alarm was not functionally duplicated during investigation testing.The freedom driver performed as intended, and there was no evidence of a device malfunction.The freedom driver was serviced and passed all final performance testing.The reported issue posed a low risk to the patient because the freedom driver continued to perform its life-sustaining functions.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.
 
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Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5738665
MDR Text Key48781928
Report Number3003761017-2016-00242
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
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 06/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2016
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 Manufacturer06/22/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2012
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 Age55 YR
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