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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 Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2024
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
It was reported that when the patient plugged their liberty select cycler into the wall outlet it sparked during preparation of their peritoneal dialysis (pd) treatment.There were no recent power outages in the home or in the area reported.There was not an outlet issue.The ok and stop keys did not make a sound when the buttons were pressed.The cycler was switched on but the stop, ok, and up/down keys did not light up.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed that there were no adverse events or medical intervention required as a result of the reported event.Stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.Confirmed that the patient has received the replacement cycler today.Confirmed that the old cycler is scheduled to be picked up and returned.
 
Event Description
It was reported that when the patient plugged their liberty select cycler into the wall outlet it sparked during preparation of their peritoneal dialysis (pd) treatment.There were no recent power outages in the home or in the area reported.There was not an outlet issue.The ok and stop keys did not make a sound when the buttons were pressed.The cycler was switched on but the stop, ok, and up/down keys did not light up.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed that there were no adverse events or medical intervention required as a result of the reported event.Stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.Confirmed that the patient has received the replacement cycler today.Confirmed that the old cycler is scheduled to be picked up and returned.
 
Manufacturer Narrative
Additional information provided in d9 and h3.Plant investigation: a visual inspection of the returned cycler exterior showed signs of physical damage due to a broken stay safe mount.There were visual indications of dried fluid within the cassette compartment.There were no visual indications of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.Voltage verification check passed.Valve actuation test passed.System air leak test passed.Post-accelerated stress test (ast) 2hr 15mins 8500ml simulated treatment was performed and encountered a grinding motor pump a.The simulated treatment was completed.Mushroom head check passed.An internal visual inspection of the returned cycler was performed.There were visual indications of dried fluid and infestation under the pump assembly on the bottom cover.The cause of the observed dried fluid could not be determined.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.The cycler was refurbished following the evaluation.
 
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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 Key18651874
MDR Text Key334746365
Report Number0002937457-2024-00219
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
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? Yes
Device AgeMO
Date Manufacturer Received01/31/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/27/2012
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 SexMale
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