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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 Problems Pain (1994); Diaphoresis (2452); Hypervolemia (2664)
Event Date 01/23/2024
Event Type  Injury  
Event Description
On 25/jan/2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) was hospitalized on (b)(6) 2024 for fluid overload.During follow-up, the patient¿s primary pd registered nurse (pdrn) reported the patient presented to the emergency room on (b)(6) 2024 with complaints of bilateral flank pain, diaphoresis, generalized weakness, and fluid overload (also treated for chronic hypothermia).The patient was admitted, and a tunneled hemodialysis (hd) catheter (not a fresenius product) was surgically placed to accommodate the patient¿s transition to hd for more rapid ultrafiltration.The patient has a preexisting arteriovenous fistula (avf), however the avf will require surgery before being used (diagnosed with steal syndrome).The patient tolerated the transition well and was discharged on (b)(6) 2024 in stable condition.The pdrn stated the patient¿s diaphoresis, weakness and flank pain all resolved after the fluid overload was corrected.The patient will not return to pd therapy and has permanently transitioned to incenter hd.The pdrn stated the patient is very challenging and is frequently non-compliant with dietary/fluid restrictions, completing treatments, and medication administration.The pdrn stated she found no evidence the patient¿s liberty select cycler malfunctioned; however, the patient refused to use it until it was replaced.The pdrn stated that due to the patient¿s non-compliance with treatments and documentation, it is impossible to know how many treatments were missed (partially vs.Completely).The pdrn also stated the non-compliance prevented her from determining when the symptoms began, or if the patient was performing manual versus cycler-based treatments.The pdrn reported the patient¿s transition to in-center hd was best for the patient, and hopefully his non-compliance (causality) can be corrected.Per the pdrn, the events were not caused by any fresenius product(s) and/or device(s) malfunction or deficiency.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: it is unknown if a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of bilateral flank pain, diaphoresis, generalized weakness, and fluid overload (also treated for chronic hypothermia), which warranted hospitalization and the permanent transition to hd for rrt.The pdrn attributed causality to the patient¿s non-compliance with his treatment plan, despite the patient¿s allegation of liberty select cycler malfunction.The pdrn reported the serious adverse events were unrelated to the patient¿s utilization of a fresenius device(s) and/or product(s).Fluid overload is a common finding among dialysis patients and is frequently multifactorial in its etiology.Based on the information available, the liberty select cycler can be excluded from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device(s) and/or product(s) failed to meet the manufacturers¿ specifications.
 
Manufacturer Narrative
Correction provided in b5.Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
On 25/jan/2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) was hospitalized on (b)(6) 2024 for fluid overload.During follow-up, the patient¿s primary pd registered nurse (pdrn) reported the patient presented to the emergency room on (b)(6) 2024 with complaints of bilateral flank pain, diaphoresis, generalized weakness, and fluid overload (also treated for chronic hypothermia).The patient was admitted, and a tunneled hemodialysis (hd) catheter (not a fresenius product) was surgically placed to accommodate the patient¿s transition to hd for more rapid ultrafiltration.The patient has a preexisting arteriovenous fistula (avf), however the avf will require surgery before being used (diagnosed with steal syndrome).The patient tolerated the transition well and was discharged on (b)(6) 2024 in stable condition.The pdrn stated the patient¿s diaphoresis, weakness and flank pain all resolved after the fluid overload was corrected.The patient will not return to pd therapy and has permanently transitioned to incenter hd.The pdrn stated the patient is very challenging and is frequently non-compliant with dietary/fluid restrictions, completing treatments, and medication administration.The pdrn stated she found no evidence the patient¿s liberty select cycler malfunctioned; however, the patient refused to use it until it was replaced.The pdrn stated that due to the patient¿s non-compliance with treatments and documentation, it is impossible to know how many treatments were missed (partially vs.Completely).The pdrn also stated the non-compliance prevented her from determining when the symptoms began, or if the patient was performing manual versus cycler-based treatments.The pdrn reported the patient¿s transition to in-center hd was best for the patient, and hopefully his non-compliance (causality) can be corrected.Per the pdrn, the events were not caused by any fresenius product(s) and/or device(s) malfunction or deficiency.
 
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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 Key18698060
MDR Text Key335297838
Report Number0002937457-2024-00255
Device Sequence Number1
Product Code FKX
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 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received02/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2012
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; Hospitalization; Required Intervention; Required Intervention;
Patient Age55 YR
Patient SexMale
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