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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
Model Number 180343
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
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 a spark was coming from a peritoneal dialysis (pd) patient¿s cycler.The patient contact reported there was a spark on the power cord near the back of the cycler during drain 1 of 5 of treatment.No smoke or burning smell was noted.The contact stated the cycler touchscreen went dark after the spark occurred and no longer turned on.The patient was connected during the incident.There was no power outage or noted outlet issue, and the power cord was securely plugged on.The cycler was switched on and there was no sound when the ok/stop buttons were pressed and no light on the cycler buttons or iq drive.At that point in time, the technical support representative advised the patient to discontinue use of the cycler.It was reported that an alternate treatment was available.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed there was no patient involvement as the patient was connected to the cycler and was in drain 1 of 5 of treatment when the reported event occurred the pdrn confirmed that there was no harm because of this malfunction.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn indicated the cycler had never been dropped nor physically damaged and confirmed that the spark only occurred once on the day the patient contact called into technical support.The pdrn stated that no burning smell melting or flame was noted.The pdrn stated that the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The pdrn confirmed the patient received a replacement cycler and has had no further issues.The cycler has been returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Additional information: plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection showed no signs of physical damage.The cycler passed a simulated treatment (post-accelerated stress test) for 2 hours and 15 minutes with 8500ml without any failures or problems.The cycler passed a voltage test, catch post hi pot test, patient hi pot test and safety analyzer test.There were no visual discrepancies encountered during the internal inspection of the cycler.There were no indications of sparking occurring or any visual evidence of any heat damage on or within the cycler.The cycler did not power off or on its own during the above testing.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.Upon completion of the evaluation, the reported issue was unconfirmed and the cause could not be determined.The cycler was refurbished following the evaluation.
 
Event Description
It was reported that a spark was coming from a peritoneal dialysis (pd) patient¿s cycler.The patient contact reported there was a spark on the power cord near the back of the cycler during drain 1 of 5 of treatment.No smoke or burning smell was noted.The contact stated the cycler touchscreen went dark after the spark occurred and no longer turned on.The patient was connected during the incident.There was no power outage or noted outlet issue, and the power cord was securely plugged on.The cycler was switched on and there was no sound when the ok/stop buttons were pressed and no light on the cycler buttons or iq drive.At that point in time, the technical support representative advised the patient to discontinue use of the cycler.It was reported that an alternate treatment was available.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed there was no patient involvement as the patient was connected to the cycler and was in drain 1 of 5 of treatment when the reported event occurred the pdrn confirmed that there was no harm because of this malfunction.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn indicated the cycler had never been dropped nor physically damaged and confirmed that the spark only occurred once on the day the patient contact called into technical support.The pdrn stated that no burning smell melting or flame was noted.The pdrn stated that the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The pdrn confirmed the patient received a replacement cycler and has had no further issues.The cycler has been returned to the manufacturer for physical 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
MDR Report Key12262799
MDR Text Key264723782
Report Number2937457-2021-01590
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861102068
UDI-Public00840861102068
Combination Product (y/n)N
PMA/PMN Number
K181108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 08/13/2021
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 Operator Lay User/Patient
Device Model Number180343
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2021
Device AgeMO
Initial Date Manufacturer Received 07/28/2021
Initial Date FDA Received08/02/2021
Supplement Dates Manufacturer Received08/12/2021
Supplement Dates FDA Received08/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET
Patient Age76 YR
Patient Weight93
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