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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 Problems Thermal Decomposition of Device (1071); Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A patient contact reported that a peritoneal dialysis (pd) patient had a physical damage to their power cord of their cycler.The patient contact reported that the power went out at the patients home during an unknown step of treatment.The power cord was unplugged from the wall and the power suddenly came back on and caused a spark.The patient contact stated that the end of the power cord plug looked burnt.The patient contact was advised to discontinue the use of the cycler and follow up with their peritoneal dialysis registered nurse (pdrn).Additional information was requested, however; to date has not been provided.
 
Manufacturer Narrative
Additional information: d9.H3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed power entry module (located on the returned cycler¿s rear panel) was damaged.The power-on verification failed.The power cord was inserted to the power entry module and the power switch was set to on, but the cycler did not power on.An internal visual inspection found the spade connectors on the power entry module were disconnected, and the tab connectors were contacting each other.There were visual indications of charring on the power entry module tab connectors.The damaged power entry module was replaced with a known good power entry module to proceed with investigation.The cycler was able to power on.No other discrepancies were found during the internal visual inspection.The catch-post hipot test, the patient hipot test, and the current leakage test were performed and passed.The returned cycler¿s voltage values, current leakage values, and enclosure leakage values were in tolerance for a liberty cycler.An as-received 11500ml cycle-based continuous cyclic peritoneal dialysis (ccpd) simulated treatment was performed and passed without further alarms or issues.The system air leak test, the valve actuation, the voltage check, and the patient pressure sensor calibration check all passed.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 confirmed.The cycler was refurbished following the evaluation.
 
Event Description
A patient contact reported that a peritoneal dialysis (pd) patient had a physical damage to their power cord of their cycler.The patient contact reported that the power went out at the patient¿s home during an unknown step of treatment.The power cord was unplugged from the wall and the power suddenly came back on and caused a spark.The patient contact stated that the end of the power cord plug looked burnt.The patient contact was advised to discontinue the use of the cycler and follow up with their peritoneal dialysis registered nurse (pdrn).Additional information was requested, however; to date has not been provided.
 
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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 Key11788258
MDR Text Key249395688
Report Number2937457-2021-00998
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
Type of Report Initial,Followup
Report Date 06/29/2021
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 Manufacturer06/07/2021
Device AgeMO
Initial Date Manufacturer Received 04/19/2021
Initial Date FDA Received05/06/2021
Supplement Dates Manufacturer Received06/17/2021
Supplement Dates FDA Received06/29/2021
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 ; DELFLEX PD FLUID; LIBERTY CYCLER SET 
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