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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number RTLR180111
Device Problem Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 03/18/2018
Event Type  malfunction  
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A peritoneal dialysis (pd) patient received a cycler and when the cycler was plugged in sparks reportedly came from the outlet.The patient stated she tried plugging the cycler into two different outlets and the same thing happened.The patient also tried switching the cord with another cycler power cord but still the sparks occurred when plugged in.The issue occurred prior to patient treatment and the patient's cycler was replaced.The patient was able to complete pd treatment on another cycler without issue.Additional follow-up was made with the pd patient's clinic registered nurse (rn), who confirmed no smoke or visible flames were noted, and no damage to the power outlets were noted.
 
Manufacturer Narrative
Plant investigation: the cycler was returned for investigation.An external visual inspection showed no signs of physical damage.Upon turning on the cycler, some lights and sparks could be seen from within the cycler and then the outlet would be blown out.An internal inspection showed that the ground wires that come from the power entry module were making contact with other metal parts causing the cycler to short out.The issue will be resolved in production.There were no other discrepancies encountered during the internal inspection of the cycler.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.
 
Event Description
A peritoneal dialysis (pd) patient received a cycler and when the cycler was plugged in sparks reportedly came from the outlet.The patient stated she tried plugging the cycler into two different outlets and the same thing happened.The patient also tried switching the cord with another cycler power cord but still the sparks occurred when plugged in.The issue occurred prior to patient treatment and the patient's cycler was replaced.The patient was able to complete pd treatment on another cycler without issue.Additional follow-up was made with the pd patient's clinic registered nurse (rn), who confirmed no smoke or visible flames were noted, and no damage to the power outlets were noted.
 
Event Description
A peritoneal dialysis (pd) patient received a cycler and when the cycler was plugged in sparks reportedly came from the outlet.The patient stated she tried plugging the cycler into two different outlets and the same thing happened.The patient also tried switching the cord with another cycler power cord but still the sparks occurred when plugged in.The issue occurred prior to patient treatment and the patient's cycler was replaced.The patient was able to complete pd treatment on another cycler without issue.Additional follow-up was made with the pd patient's clinic registered nurse (rn), who confirmed no smoke or visible flames were noted, and no damage to the power outlets were noted.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
LIBERTY CYCLER
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key7354170
MDR Text Key102950731
Report Number2937457-2018-00828
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861100972
UDI-Public00840861100972
Combination Product (y/n)N
PMA/PMN Number
K123630
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 04/20/2018
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 Catalogue NumberRTLR180111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Device AgeMO
Initial Date Manufacturer Received 03/18/2018
Initial Date FDA Received03/20/2018
Supplement Dates Manufacturer Received04/02/2018
04/20/2018
Supplement Dates FDA Received04/02/2018
04/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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