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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
Model Number 595000-001
Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the right spring on the cpc connector was displaced, the freedom driver continued to perform its life-sustaining functions.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that the right cpc connector (circular plastic connector) on the freedom driver had a displaced spring.The customer also reported that the patient was subsequently switched to a backup freedom driver.There was no reported adverse patient impact.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.The customer-reported issue of a displaced spring in the cpc connector was confirmed during the visual inspection of the driver's external components.Despite the displaced spring, the drivelines were able to be connected to a tah-t during investigation testing and the driver passed all test sections in freedom driver final test and acceptance procedure.It cannot be conclusively determined when the spring became displaced within the housing; however, the most likely root cause based on the available evidence is that the spring was displaced/became misaligned after a previous driver switch out.Syncardia has an open corrective and preventive action (capa) to address this issue with cpc connectors.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
Event Description
The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that the right cpc connector (circular plastic connector) on the freedom driver had a displaced spring.The customer also reported that the patient was subsequently switched to a backup freedom driver.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 Key7013891
MDR Text Key92750362
Report Number3003761017-2017-00203
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 Health Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number595000-001
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2011
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 Age39 YR
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