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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 Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the freedom driver of the patient at (b)(6) made a strange noise and the patient did not feel well.The customer also reported that the patient was subsequently switched to a backup freedom driver and that the patient felt better after the driver switch.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a noise, 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 freedom driver of the patient at (b)(6) made a strange noise and the patient did not feel well.The customer also reported that the patient was subsequently switched to a backup freedom driver and that the patient felt better after the driver switch.The freedom driver was returned to syncardia for evaluation.Visual inspection of the exterior of the driver revealed no anomalies.Visual inspection of the interior revealed that a driveline connection clamp, fastening screw and lock washer were loose inside the housing.During investigation testing, the driver passed all test acceptance criteria, which included normotensive and hypertensive settings, with no anomalies or alarms.The driver was tested for an additional 48 hours at normotensive settings and performed as intended with no anomalies or alarms.The driver performed as intended, and there was no evidence of a device malfunction.The noise reported by the customer was likely caused by the loose hardwire inside the driver housing.The loose components met dimensional specifications, and it is unknown how the components became loose.The driver was serviced and returned to finished goods for clinical use.The reported issue posed a low risk to the patient because although the freedom driver exhibited a noise, 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 Key5704120
MDR Text Key48011085
Report Number3003761017-2016-00229
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000002131
UDI-Public(01)00858000002131
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
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 Manufacturer06/13/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/25/2016
Initial Date FDA Received06/07/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2012
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 Outcome(s) Required Intervention;
Patient Age51 YR
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