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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 Problems Component Falling (1105); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the connection 1 receptacle that attaches on the power adaptor fell into the freedom driver housing.The freedom driver was exchanged without any adverse patient impact.This alleged failure mode poses a low risk to the patient because it does not prevent the freedom driver from performing 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 connection 1 receptacle that attaches on the power adaptor fell into the freedom driver housing.The freedom driver was exchanged without any adverse patient impact.This alleged failure mode poses a low risk to the patient because it does not prevent the freedom driver from performing its life-sustaining functions.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed the connection 1 receptacle, which connects the power adaptor to the driver, was no longer attached to the housing and was lodged inside the housing.This confirmed the customer-reported issue.It is unknown how the connection one receptacle was damaged but is consistent with the result of the application of excessive force in connecting the power adaptor to the driver.Visual inspection of the driver's internal components revealed fractured housing bosses and raised inserts.The root cause is unknown but the damaged observed is consistent with an impact shock, which is also evidenced by the cracked housing.Despite the damaged connection 1 receptacle, the driver met all pressure test acceptance criteria, which included normotensive and hypertensive settings.This failure mode posed a low risk to the patient because the driver continued to perform its life-sustaining functions.The freedom driver utilizes multiple redundant power sources, which includes external power via ac power supply, car charger, and battery power.Patients are equipped with several freedom onboard batteries that can be charged via a separate battery charger.The driver was serviced, which included the replacement of the connection 1 receptacle, main printed circuit board assembly (pcba), speaker pcba, piston and cylinder assembly (pca), motor/gearbox assembly and housings, before being placed into finished goods.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 Key5039203
MDR Text Key25227222
Report Number3003761017-2015-00265
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Followup
Report Date 08/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2015
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 Manufacturer08/26/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2012
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 Age44 YR
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