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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYNCARDIA PRIMARY FREEDOM DRIVER
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SYNCARDIA SYNCARDIA PRIMARY FREEDOM DRIVER Back to Search Results
Device Problems Failure to Align (2522); Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Date 05/11/2017
Event Type  Injury  
Event Description
Syncardia freedom driver was changed to backup freedom driver at 0145, bedside in 8 cooley a bed 04, due to a continuous alarm.During the freedom driver exchange, the spring beneath the lever to unlatch the connection of the cannula was misaligned.Because of this, the latch was not able to be disconnected.Css staff had to quickly replace the whole connection as the freedom driver exchange was done.New primary freedom driver sn: (b)(4) new backup freedom driver sn: (b)(4).Old freedom driver sn: (b)(4).Patient tolerated exchange well and no hemodynamic instability.Old freedom was collected and will be sent back to syncardia for analysis.
 
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Brand Name
SYNCARDIA PRIMARY FREEDOM DRIVER
Type of Device
SYNCARDIA PRIMARY FREEDOM DRIVER
Manufacturer (Section D)
SYNCARDIA
tucson AZ 85713
MDR Report Key6705832
MDR Text Key79951953
Report NumberMW5070924
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/07/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age56 YR
Patient Weight74
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