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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 Erratic or Intermittent Display (1182); Filling Problem (1233)
Patient Problems Dyspnea (1816); Hyperventilation (1910)
Event Date 11/11/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the freedom driver exhibited fluctuating fill volumes when the patient would stand up at home.The customer also reported that the patient experienced periodic episodes of shortness of breath during the time of the event.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient felt fine after he was switched.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).Follow-up report 1.
 
Event Description
The customer reported that the freedom driver exhibited fluctuating fill volumes when the patient would stand up at home.The customer also reported that the patient experienced periodic episodes of shortness of breath during the time of the event.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient felt fine after he was switched.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no abnormalities.The driver in "as received" condition passed all required test requirements, which included normotensive and hypertensive settings, with no anomalies or alarms.In addition, the driver was tested for an additional 48 hours and performed as intended with exception to a slightly elevated patient simulated lap (left atrial pressure) above the maximum normotensive specification of 17 mmhg (millimeters of mercury) (actual was 18 mmhg).It is not uncommon for lap to differ across a range of three (3) mmhg during testing as the patient simulator continues to stabilize over time.There was no evidence of a drop in cardiac output; therefore, despite the elevated lap, the driver continued to perform its life-sustaining functions.Review of the driver's alarm history revealed one low cardiac output fault alarm that was recorded as a result of the measured cardiac output on the driver being below 3.5 lpm (liters per minute).This alarm only becomes recorded in the driver's history after the first fifteen minutes upon startup and after approximately four minutes and fifteen seconds in the alarm state.This alarm did not occur at syncardia, and the customer did not report any fault alarms.The customer experience was not duplicated during the investigation, and there was no evidence of a device malfunction.Therefore, the root cause of the customer-reported low cardiac output could not be determined.Despite the customer-reported low cardiac output, risk to the patient was low because the driver continued to perform its life-sustaining functions.The driver was serviced, which included the replacement of the pca (piston cylinder assembly) as a precautionary measure, 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 Key5242775
MDR Text Key32159967
Report Number3003761017-2015-00391
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 Initial,Followup
Report Date 11/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2015
Is this an Adverse Event Report? Yes
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 Manufacturer11/30/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2015
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 Age42 YR
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