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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 06/04/2022
Event Type  Injury  
Event Description
On (b)(6) 2022 fresenius became aware that this (b)(6) male 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, allegedly due to receiving the incorrect prescription.During additional follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was hospitalized on (b)(6) 2022 due to worsening dyspnea.Radiological studies revealed the patient was in fluid overload, and the patient was placed on ccpd utilizing a 4.25% dextrose solution to promote increased fluid removal.No other diagnostic testing or procedures were performed, however the patient remained hospitalized until on (b)(6) 2022.The patient has reportedly recovered from the events and continues to perform continuous cyclic peritoneal dialysis (ccpd) at home without issue.The peritoneal dialysis registered nurse (pdrn) attributed causality to the patient not adding a last fill and daytime exchange to his prescription as ordered.The patient is non-compliant with fluid intake which required the patient to perform a last fill and daytime exchange, however the patient purposefully did not perform the additional exchanges, which led to fluid overload.The patient¿s prescription has been updated and education was provided.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler, and the serious adverse events of fluid overload (characterized by dyspnea), which required hospitalization.The peritoneal dialysis registered nurse (pdrn) attributed causality to the patient¿s non-adherence to the pd prescription.The patient reportedly failed to perform a last fill and daytime exchange as ordered, which led to fluid overload.The pdrn reported the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Fluid overload is a well-known potential complication of the end stage renal dialysis (esrd) process.Furthermore, causality can often be attributed to several different internal and external factors such as, physiological changes, mechanical issues, membrane/transport failure.Additionally, patient related factors such as non-compliance (unintentional or otherwise) can be a significant contributing factor, thus limiting the efficacy of rrt.Based on the available information, the patient¿s liberty select cycler is disassociated from the events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred.
 
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
On (b)(6) 2022 fresenius became aware this 67-year-old male 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, allegedly due to receiving the incorrect prescription.During additional follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was hospitalized on (b)(6) 2022 due to worsening dyspnea.Radiological studies revealed the patient was in fluid overload, and the patient was placed on ccpd utilizing a 4.25% dextrose solution to promote increased fluid removal.No other diagnostic testing or procedures were performed, however the patient remained hospitalized until (b)(6) 2022.The patient has reportedly recovered from the events and continues to perform continuous cyclic peritoneal dialysis (ccpd) at home without issue.The peritoneal dialysis registered nurse (pdrn) attributed causality to the patient not adding a last fill and daytime exchange to his prescription as ordered.The patient is non-compliant with fluid intake which required the patient to perform a last fill and daytime exchange, however the patient purposefully did not perform the additional exchanges, which led to fluid overload.The patient¿s prescription has been updated and education was provided.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.
 
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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 Key14873856
MDR Text Key295036150
Report Number0002937457-2022-01089
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 Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/26/2022
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? No
Device AgeMO
Initial Date Manufacturer Received 06/09/2022
Initial Date FDA Received06/30/2022
Supplement Dates Manufacturer Received07/13/2022
Supplement Dates FDA Received07/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2017
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) Required Intervention; Hospitalization;
Patient Age67 YR
Patient SexMale
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