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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number RTLR180343
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2024
Event Type  malfunction  
Event Description
A peritoneal dialysis (pd) patient reported a display brightness problem with the cycler screen.The screen was dim on the right side while the cycler was turned on.Display brightness was set to 10.The patient rebooted the cycler but screen remained dim.The technical support representative advised that the cycler would be replaced due to screen brightness problem.Upon follow up, it was confirmed that no patient adverse effects were experienced, and no medical intervention was required.The patient was able to complete treatment by performing manual treatments.The cycler was returned to the manufacturer and a replacement cycler was provided and received.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.
 
Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical investigation.A visual inspection of the returned cycler exterior showed no sign of physical damage.Touch screen test failed - when powering on the cycler the ¿ok, stop, and up/down arrows push buttons¿ illuminated, however the front panel display remained dim.An internal inspection of the cycler found transformer (t1) on the ¿inverter board¿ to have an internal short.The inverter board is located on the rear of the front panel assembly.A known good inverter board was installed and the display became operational.Removed functioning inverter board from the front panel at the completion of the investigation.Valve actuation test passed.System air leak test failed.Pressure leak traced to safety clamp leaking.Replaced pneumatic valve 23.Pressure now stable.Pre-ast 15mins 1000ml simulated treatment was performed without any failures or problems.The device history record did reveal issues or problems related to the reported symptom code(s).Front panel display replaced on 11/22/2023 upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be an internal short on the inverter board.
 
Event Description
A peritoneal dialysis (pd) patient reported a display brightness problem with the cycler screen.The screen was dim on the right side while the cycler was turned on.Display brightness was set to 10.The patient rebooted the cycler but screen remained dim.The technical support representative advised that the cycler would be replaced due to screen brightness problem.Upon follow up, it was confirmed that no patient adverse effects were experienced, and no medical intervention was required.The patient was able to complete treatment by performing manual treatments.The cycler was returned to the manufacturer and a replacement cycler was provided and received.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.
 
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Brand Name
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key19004701
MDR Text Key338919887
Report Number0002937457-2024-00526
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861102068
UDI-Public00840861102068
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K222318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2024
Device AgeMO
Date Manufacturer Received04/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; DELFLEX PD FLUID; FRESENIUS CYCLER SET; FRESENIUS CYCLER SET
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