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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 Dyspnea (1816); Muscle Weakness (1967); Pulmonary Edema (2020); Malaise (2359)
Event Date 02/20/2024
Event Type  Injury  
Event Description
The peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) utilizing the liberty select cycler for renal replacement therapy (rrt) contacted fresenius for assistance with drain complications.During the initial call, the patient reported feeling unwell (malaise) earlier in the day and was currently unable to ¿get up¿ (weakness) and having a hard time breathing (dyspnea).During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was experiencing dyspnea, weakness, malaise and slow drains during ccpd therapy on (b)(6) 2024.Following the call, the pdrn performed a home evaluation where it was noted the patient¿s liberty select cycler was approximately 5 to 6 inches higher than the bed (as recommended by the manufacturer).The patient reportedly refused to adjust the cycler height due to being unhappy with the cart provided by the home therapy department.On (b)(6) 2024, the patient was evaluated by their primary care physician and instructed to go to the hospital for evaluation of fluid in their lungs (pulmonary edema).As of (b)(6) 2024 the patient remained hospitalized and was transitioned to hemodialysis (hd) for rrt.According to the pdrn, the patient¿s pulmonary edema was likely caused by the over elevation of the liberty select cycler.However, due to the patient¿s ongoing hospitalization, the definitive cause cannot be confirmed.
 
Manufacturer Narrative
Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of pulmonary edema, characterized by malaise, weakness, and dyspnea, which warranted hospitalization and the transition to hd for rrt.Per the pdrn, the patient¿s pulmonary edema was likely caused by the over elevation of the liberty select cycler.However, due to the patient¿s ongoing hospitalization, the definitive cause cannot be established.Pulmonary edema is a well-known potential complication of the esrd process, and causality can often be attributed to several different internal and external factors such as, physiological/cardiac changes, dietary restrictions, mechanical issues, membrane/transport failure.Based on the information available, the patient¿s liberty select cycler can be excluded from having directly caused the patient¿s serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused or contributed to the serious adverse events.Furthermore, despite the reported drain complications, there was no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations or manufacturers¿ specifications.The patient stated they understood the manufacturers¿ recommendations regarding cycler height, but willfully chose to disregard them (non-compliance).The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Manufacturer Narrative
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
The peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) utilizing the liberty select cycler for renal replacement therapy (rrt) contacted fresenius for assistance with drain complications.During the initial call, the patient reported feeling unwell (malaise) earlier in the day and was currently unable to ¿get up¿ (weakness) and having a hard time breathing (dyspnea).During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was experiencing dyspnea, weakness, malaise and slow drains during ccpd therapy on (b)(6) 2024.Following the call, the pdrn performed a home evaluation where it was noted the patient¿s liberty select cycler was approximately 5 to 6 inches higher than the bed (as recommended by the manufacturer).The patient reportedly refused to adjust the cycler height due to being unhappy with the cart provided by the home therapy department.On (b)(6) 2024, the patient was evaluated by their primary care physician and instructed to go to the hospital for evaluation of fluid in their lungs (pulmonary edema).As of (b)(6) 2024 the patient remained hospitalized and was transitioned to hemodialysis (hd) for rrt.According to the pdrn, the patient¿s pulmonary edema was likely caused by the over elevation of the liberty select cycler.However, due to the patient¿s ongoing hospitalization, the definitive cause cannot be confirmed.
 
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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 Key18807917
MDR Text Key336621469
Report Number0002937457-2024-00349
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 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2024
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 Received03/07/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2010
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 Age55 YR
Patient SexFemale
Patient Weight75 KG
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