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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 LIBERTY SEL
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2022
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 during step 7 of setup.The patient was not connected during incident.The patient stated they bumped into the cycler and caused a spark in the back of the cycler.The display screen went black, the power cord was not securely plugged in, and the power switch was in the on position.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 not available.A replacement cycler was issued to the patient.Additional information was requested but was not received to date.
 
Manufacturer Narrative
Additional information: b5.
 
Event Description
It was reported that a spark was coming from a peritoneal dialysis (pd) patient¿s cycler during step 7 of setup.The patient was not connected during incident.The patient stated they bumped into the cycler and caused a spark in the back of the cycler.The display screen went black, the power cord was not securely plugged in, and the power switch was in the on position.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 not available.A replacement cycler was issued to the patient.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) stated the machine was all set up and the patient accidently tugged on power cord and noticed sparks appearing.Then the machine turned off and wouldn't turn back on.There was no change in the patient's status as it relates to the reported event.The patient was not able to continue therapy after the reported event and treatment was cancelled.There was no effect on outcome of the patient's current status as related to the reported event.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.
 
Manufacturer Narrative
Plant investigation: a visual inspection of the returned cycler exterior showed no signs of physical damage.There were visual indications of dried fluid within the cassette compartment on the top cover and on the pump door.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.The catch-post hipot test, patient hipot test, current leakage test, touchscreen test and voltage calibration check passed.A post-accelerated stress test (ast) was performed and passed with no further alarms or issues.Found no discrepancies with the mushroom heads during the mushroom head checks.An internal visual inspection of the returned cycler was performed.There were visual indications of dried fluid on the bottom cover under the pump.The cause of the observed dried fluid could not be determined.All electrical testing passed, no evidence of an electrical spark was reproduced during the investigation.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 and did not reveal any issues or problems related to the reported symptom codes.Upon completion of the evaluation, the reported issue was unconfirmed.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 during step 7 of setup.The patient was not connected during incident.The patient stated they bumped into the cycler and caused a spark in the back of the cycler.The display screen went black, the power cord was not securely plugged in, and the power switch was in the on position.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 not available.A replacement cycler was issued to the patient.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) stated the machine was all set up and the patient accidently tugged on power cord and noticed sparks appearing.Then the machine turned off and wouldn't turn back on.There was no change in the patient's status as it relates to the reported event.The patient was not able to continue therapy after the reported event and treatment was cancelled.There was no effect on outcome of the patient's current status as related to the reported event.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.
 
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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 Key13801404
MDR Text Key287408795
Report Number2937457-2022-00405
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861102068
UDI-Public00840861102068
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 06/08/2022
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 NumberLIBERTY SEL
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? Device Returned to Manufacturer
Device AgeMO
Initial Date Manufacturer Received 03/11/2022
Initial Date FDA Received03/17/2022
Supplement Dates Manufacturer Received03/24/2022
06/07/2022
Supplement Dates FDA Received03/30/2022
06/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/30/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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