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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
Catalog Number RTLR180343
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.The file was assessed to determine whether a clinical investigation is warranted.On (b)(6) 2019, fresenius became aware a patient with renal failure (rf) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy was hospitalized (specifics and dates not provided).Subsequent attempts to obtain additional information have thus far proven unsuccessful.Based on the information available, the liberty select cycler and fmc cassette are disassociated from the event(s), as there is no allegation or objective evidence indicating a product deficiency or malfunction caused or contributed to the patient¿s hospitalization.Therefore, the completion of a clinical investigation is not warranted at this time.Should additional information become available the need for a clinical investigation will be reassessed accordingly.
 
Event Description
A hospital nurse called in to report a fluid leak during an unknown patient's peritoneal dialysis (pd) treatment on the liberty select cycler.The fluid leak is captured and investigated in a separate record.Patient information and reason for patient's hospitalization was not reported.Multiple attempts were made to acquire additional information, however, to this date no response has been received.
 
Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.Upon opening the cassette compartment, there were visual indications of dried fluid within the cassette compartment.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.An accelerated stress test (ast) was performed and passed without any fluid leaks.A two hour and fifteen minute simulated treatment with 8500ml was performed and completed without failures.The cycler underwent and passed a valve actuation test and system air leak test.The cycler tested positive for glucose.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal visual inspection identified evidence of dried fluid beneath the mushroom heads of pump a and b and within the recess of the bottom cover adjacent to the pump.The cause of the dried fluid could not be determined.There were no other visual discrepancies observed during internal inspection.A review of the device manufacturing records was conducted by the manufacturer.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, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.
 
Event Description
A hospital nurse called in to report a fluid leak during an unknown patient's peritoneal dialysis (pd) treatment on the liberty select cycler.The fluid leak is captured and investigated in a separate record.Patient information and reason for patient's hospitalization was not reported.Multiple attempts were made to acquire additional information, however, to this date no response has been received.The cycler was 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
4040 nelson avenue
concord CA 94520
MDR Report Key8940381
MDR Text Key155961669
Report Number2937457-2019-02758
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 health professional,user faci
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2019
Device AgeMO
Initial Date Manufacturer Received 08/10/2019
Initial Date FDA Received08/28/2019
Supplement Dates Manufacturer Received09/06/2019
Supplement Dates FDA Received09/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; LIBERTY CYCLER SET
Patient Outcome(s) Hospitalization;
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