Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Filling Problem (1233); Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)
Patient Problem Pulmonary Edema (2020)
Event Date 05/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the patient's freedom driver exhibited an intermittent fault alarm, and the patient's fill volumes (fv) varied between 21 and 50.The customer also reported that the patient had pulmonary edema amd was hospitalized at (b)(6) and switched to a companion 2 driver.The freedom driver will be returned to syncardia for investigation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The patient was transplanted nine days after this customer-reported issue.The freedom driver was returned to syncardia for investigation.Review of the alarm history (eeprom) revealed one recorded alarm, fault code 4a, which correlates to, "left drive pressure too low for long enough to be a permanent time out." this alarm is typically associated with driver exchange but can also occur when there is a malfunction of the piston cylinder assembly (pca).The investigation testing confirmed the cause for the customer-reported issue was a malfunction of the pca.The pca has been sent to an external laboratory for further analysis.The results of that analysis will be provided in a follow-up mdr.(b)(4) follow-up report 1.
 
Event Description
The customer reported that the patient's freedom driver exhibited an intermittent fault alarm, and the patient's fill volumes (fv) varied between 21 and 50.The customer also reported that the patient had pulmonary edema and was hospitalized at l'hôpital de la pitié and switched to a companion 2 driver.
 
Manufacturer Narrative
The piston cylinder assembly (pca) was sent to an external laboratory for further analysis.The external laboratory findings and customer supplied information determined that the loss of left side pressure in the submitted piston cylinder assembly was caused by a malfunctioned 4.2 psi check valve which likely became dislodged due to deterioration of a rubber retaining o-ring.This is the first observed occurrence of this issue and will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of the complaint and is closing this file.(b)(4).
 
Event Description
The customer reported that the patient's freedom driver exhibited an intermittent fault alarm, and the patient's fill volumes (fv) varied between 21 and 50.The customer also reported that the patient had pulmonary edema and was hospitalized at (b)(6) and switched to a companion 2 driver.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5683750
MDR Text Key46913189
Report Number3003761017-2016-00221
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 distributor,foreign,health pr
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 05/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2016
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 Manufacturer05/27/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2012
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 Age30 YR
-
-