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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 Problems Fluid/Blood Leak (1250); Overfill (2404)
Patient Problems Chest Pain (1776); Dyspnea (1816); Hypervolemia (2664)
Event Date 08/27/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, 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 nurse reported that the patient was hospitalized on (b)(6) 2017.The reason for hospitalization was shortness of breath and fluid overload.The patient was discharged from the hospital on (b)(6) 2017 and recovered status and no change in treatment modality.The patient was re-educated regarding the pd therapy.Patient has a medical history of diabetes and hypertension.The patient continues with peritoneal dialysis therapy with no further issues.
 
Manufacturer Narrative
Clinical evaluation: it is unknown if there is a temporal relationship between the patients¿ hospitalization for shortness of breath and fluid overload and the liberty cycler.However, there is a strong probability that the reported non-compliance of the patient contributed to the event.Of note there has been no allegation against any fresenius device(s) and the event.Should additional information be made available this clinical investigation will be reevaluated.
 
Event Description
A peritoneal dialysis nurse reported that the patient was hospitalized on (b)(6) 2017.The reason for hospitalization was shortness of breath and fluid overload.The patient was discharged from the hospital on (b)(6) 2017 and recovered status and no change in treatment modality.The patient was re-educated regarding the pd therapy.Patient has a medical history of diabetes and hypertension.The patient continues with peritoneal dialysis therapy with no further issues.
 
Manufacturer Narrative
Corrective data: preexisting medical conditions added.Patient and device codes have been updated.
 
Event Description
A peritoneal dialysis nurse reported that the patient was hospitalized on (b)(6) 2017.The reason for hospitalization was shortness of breath and fluid overload.The patient was discharged from the hospital on (b)(6) 2017 and recovered status and no change in treatment modality.The patient was re-educated regarding the pd therapy.Patient has a medical history of diabetes and hypertension.The patient continues with peritoneal dialysis therapy with no further issues.
 
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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 Key6899054
MDR Text Key87590706
Report Number2937457-2017-00967
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 health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberRTLR180111
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received04/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LIBERTY CYCLER SET; PD FLUID
Patient Outcome(s) Hospitalization;
Patient Age76 YR
Patient Weight97
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