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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 07/04/2021
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
A peritoneal dialysis (pd) patient reported to fresenius technical support that the liberty select cycler sparked after it was powered on.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was not available.Additional information was requested, however a response was not received.It was not stated in the initial report that the patient experienced a serious injury, adverse event, or required medical intervention as a result of the reported issue.The cycler was scheduled to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer.No physical damage was noted during an external visual inspection.A post- accelerated stress test (ast) simulated treatment was initiated and completed without failures.The cycler underwent and passed a voltage test, catch post hi pot test, a patient hi pot test, and a safety analyzer test.There were no visual discrepancies observed during the internal inspection.A review of the device manufacturing records was conducted and 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, no malfunctions were found that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.The cycler was refurbished following the evaluation.
 
Event Description
A peritoneal dialysis (pd) patient reported to fresenius technical support that the liberty select cycler sparked after it was powered on.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was not available.Additional information was requested, however a response was not received.It was not stated in the initial report that the patient experienced a serious injury, adverse event, or required medical intervention as a result of the reported issue.The cycler was scheduled to be 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 Key12220876
MDR Text Key263387092
Report Number2937457-2021-01548
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 08/03/2021
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 Manufacturer07/21/2021
Device AgeMO
Initial Date Manufacturer Received 07/04/2021
Initial Date FDA Received07/23/2021
Supplement Dates Manufacturer Received07/28/2021
Supplement Dates FDA Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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