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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 04/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
Event Description
The customer reported that the freedom driver exhibited abnormal noises while supporting a patient.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited abnormal noises, 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 exhibited abnormal noises while supporting a patient.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the exterior of the driver revealed no abnormalities.Visual inspection of the interior of the driver revealed a fractured housing boss, unretracted battery safety latch and loose hose connection clamp, fastening screw and lock washer, which were indicative of an impact shock to the driver.Review of the alarm history (eeprom) did not reveal any alarms that occurred while the driver was supporting the patient.The driver was functionally tested and 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 functioned as intended.The root cause for the reported noise was the loose components inside the driver, likely resulting from an impact shock to the driver.The driver was repaired and serviced and passed all final performance testing.The clinical staff at the hospital confirmed that all tah-t patients discharged to home with a freedom driver receive training on what to do in the event that the freedom driver is dropped or is subjected to an impact shock.In addition, the "freedom driver system guidebook for patients and caregivers" states, at section 4.2 - warnings: "if the freedom driver or any of the accessories are dropped, they must be brought back to the hospital for replacement." the reported issue posed a low risk to the patient because it did not prevent the freedom driver from performing 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 Key5627240
MDR Text Key45235176
Report Number3003761017-2016-00165
Device Sequence Number1
Product Code LOZ
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 foreign,health professional,u
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 04/14/2016
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 Health Professional
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/14/2016
Initial Date FDA Received05/03/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2015
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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