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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problem Audible Prompt/Feedback Problem (4020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2023
Event Type  malfunction  
Event Description
The customer, a syncardia authorized distributor, reported the freedom driver had multiple red alarms during regular medical control in the hospital.The patient was sitting and all parameters were normal.The patient was switched to a back up driver.
 
Manufacturer Narrative
The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
 
Event Description
The customer, a syncardia authorized distributor, reported the freedom driver had multiple red alarms during regular medical control in the hospital.The patient was sitting and all parameters were normal.The patient was switched to a back up driver.
 
Manufacturer Narrative
Device history record (dhr) review confirmed that freedom driver s/n (b)(6), was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found one new alarm indicating cardiac output was low enough for long enough to exhibit a permanent time-out.Visual inspection of external components found damage to the fan cover and external power cable 7-pin connector.Visual inspection of internal components found anchor boss on the bottom right front housing is cracked and nut out of placement.Freedom driver failed functional testing at incoming inspection.Asterisks were present on lcd display screen for fill volume and cardiac output.A red alarm enunciated during testing approximately 10-15 minutes after powering on.Observational testing suggested the alarm was likely due to a faulty airflow sensor.A known functioning test airflow sensor cable and airflow sensor were used to identify the root problem.Testing with the replacement airflow sensor produced no alarms and displayed fill volume and cardiac output values without issue.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated; root cause of the red fault alarms and lcd display errors was determined to be a faulty airflow sensor.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated; root cause of the red fault alarms and lcd display errors was determined to be a faulty airflow sensor.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Damage found to the fan cover and power cable connector, as well as the cracked anchor boss on the front housing, was cosmetic only.Driver did not function as designed.Patient was switched to a backup driver with no reported adverse impact.Syncardia has completed its evaluation 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, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer (Section G)
SYNCARDIA SYSTEMS, LLC
1992 e silverlake road
tucson AZ 85713
Manufacturer Contact
aaron meier
1992 e silverlake road
tucson, AZ 85713
5205451234
MDR Report Key16872936
MDR Text Key314732699
Report Number3003761017-2023-00064
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/06/2023
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 Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 04/27/2023
Initial Date FDA Received05/04/2023
Supplement Dates Manufacturer Received04/27/2023
Supplement Dates FDA Received12/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2017
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 Age62 YR
Patient SexMale
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