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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 03/29/2021
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 powered up the cycler which tripped every outlet in the house and sparked, causing a black mark on the cycler power cord.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 stated that there was no patient involvement as the patient was not connected to the cycler.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 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
Correction: h6: investigation findings: c92045 (electrical problem identified), investigation conclusions: c139472 (cause traced to component failure).
 
Event Description
It was reported that a spark was coming from a peritoneal dialysis (pd) patient¿s cycler.The patient powered up the cycler which tripped every outlet in the house and sparked, causing a black mark on the cycler power cord.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 stated that there was no patient involvement as the patient was not connected to the cycler.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 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 had no further issues.The cycler has been returned to the manufacturer for physical evaluation.
 
Event Description
It was reported that a spark was coming from a peritoneal dialysis (pd) patient¿s cycler.The patient powered up the cycler which tripped every outlet in the house and sparked, causing a black mark on the cycler power cord.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 stated that there was no patient involvement as the patient was not connected to the cycler.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 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 had no further issues.The cycler has been returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no signs of physical damage.An internal visual inspection found the spade connectors on the power entry module were disconnected, and the tab connectors were making contact with each other.There were visual indications of charring on the power entry module tab connectors.Replaced the damaged power entry module with a known good power entry module to proceed with investigation.No other discrepancies were found during the internal visual inspection.The cycler underwent and passed a catch post hipot test, patient hipot test and safety analyzer test.A post-accelerated stress test (ast) simulated treatment was was performed and passed with no further alarms or issues.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
MDR Report Key11595854
MDR Text Key243357605
Report Number2937457-2021-00555
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 company representative,consum
Type of Report Initial,Followup,Followup
Report Date 04/30/2021
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 Manufacturer04/08/2021
Device AgeMO
Initial Date Manufacturer Received 03/29/2021
Initial Date FDA Received03/31/2021
Supplement Dates Manufacturer Received04/30/2021
04/30/2021
Supplement Dates FDA Received04/30/2021
04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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