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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Hypervolemia (2664)
Event Date 10/06/2022
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of fluid overload, characterized by dyspnea, which warranted hospitalization.The patient/pdrn allege the patient¿s liberty select cycler was malfunctioning and not performing pd therapy correctly.Fluid overload is a common finding among dialysis patients and is frequently multifactorial in its etiology.Based on the limited information available, the liberty select cycler cannot be excluded from having a possible causal or contributory role in the serious adverse events.Presently, there is no physical/objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused or contributed to the event(s).However, given the pdrns allegation, no discharge summary, no treatment data, and no manufacturer evaluation of the suspect device; there is insufficient evidence to exclude the liberty select cycler from having caused or contributed to the serious adverse events.
 
Event Description
On (b)(6) 2022, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on (b)(6) 2022, after not performing ccpd therapy since (b)(6) 2022.No additional information provided during intake.During follow-up, the patient¿s primary pdrn confirmed the patient presented to the emergency room (er) on (b)(6) 2022 with shortness of breath (dyspnea).The pdrn reported the patient underwent several x-rays, which determined the patient was fluid overloaded.The patient was admitted and was treated with ccpd therapy utilizing a hospital cycler (manufacturer unknown) and 4.25% dextrose-based dialysate to promote greater fluid removal (ultrafiltration).The pdrn reported the patient¿s dyspnea improved (still recovering) and was discharged home on (b)(6) 2022.The pdrn attributed causality to the patient¿s malfunctioning liberty select cycler.The pdrn reported the patient experienced alarms which prevented her from performing ccpd therapy for 72 hours prior to admission.The patient did have access to the correct supplies to perform continuous ambulatory pd (capd) but elected to not perform manual exchanges (rationale not provided).Following discharge, the patient resumed ccpd therapy at home utilizing the replacement liberty select cycler without reported issue.
 
Manufacturer Narrative
Additional information provided in d9 and h3.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.There was no evidence of dried fluid present within the cassette compartment.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.There were no visual indications of particulates within the cassette area.An (as received) simulated treatment was performed and completed.The cycler weighed fill volume values were within tolerance for the cycler.The cycler underwent and passed a system air leak test and valve actuation test.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal inspection of the cycler showed that there were visual indications of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the encountered dried fluid could not be determined.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.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
On 11/oct/2022, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on 6/oct/2022, after not performing ccpd therapy since 3/oct/2022.No additional information provided during intake.During follow-up, the patient¿s primary pdrn confirmed the patient presented to the emergency room (er) on 6/oct/2022 with shortness of breath (dyspnea).The pdrn reported the patient underwent several x-rays, which determined the patient was fluid overloaded.The patient was admitted and was treated with ccpd therapy utilizing a hospital cycler (manufacturer unknown) and 4.25% dextrose-based dialysate to promote greater fluid removal (ultrafiltration).The pdrn reported the patient¿s dyspnea improved (still recovering) and was discharged home on 12/oct/2022.The pdrn attributed causality to the patient¿s malfunctioning liberty select cycler.The pdrn reported the patient experienced alarms which prevented her from performing ccpd therapy for 72 hours prior to admission.The patient did have access to the correct supplies to perform continuous ambulatory pd (capd) but elected to not perform manual exchanges (rationale not provided).Following discharge, the patient resumed ccpd therapy at home utilizing the replacement liberty select cycler without reported issue.
 
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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 Key15633744
MDR Text Key302020999
Report Number0002937457-2022-01748
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,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/12/2022
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 Lay User/Patient
Device Model Number180343
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? Device Returned to Manufacturer
Device AgeMO
Initial Date Manufacturer Received 10/11/2022
Initial Date FDA Received10/19/2022
Supplement Dates Manufacturer Received12/08/2022
Supplement Dates FDA Received12/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET 
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age51 YR
Patient SexFemale
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