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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 Pneumonia (2011); Dizziness (2194); Malaise (2359)
Event Date 05/26/2023
Event Type  Injury  
Event Description
On (b)(6) 2023, a patient contact reported to fresenius technical services this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler needed to discontinue a pd treatment to report to the hospital.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient needed to discontinue a ccpd treatment on (b)(6) 2023 due to weakness, dizziness, and malaise.The patient was safely disconnected from her liberty select cycler and transported to the emergency department by a family friend.The patient was admitted to the hospital on the same day after being diagnosed with pneumonia, attributed to the patient¿s pulmonary comorbidities.There was no indication of a causal relationship to pd therapy or cycler use.The patient has been able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) for the duration of the admission.The patient is recovering from this event while awaiting discharge home.It was confirmed that the patient¿s pneumonia and associated symptoms were unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue ccpd therapy on the same liberty select cycler at home upon discharge.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is no allegation or objective evidence indicating a serious patient injury, death, or other adverse event(s) occurred while utilizing a fresenius medical device(s) and/or product(s).Additionally, there is no allegation or objective evidence a fresenius device(s) and/or product(s) failed to meet user expectations or manufacturer specifications.
 
Event Description
On (b)(6) 2023, a patient contact reported to fresenius technical services this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler needed to discontinue a pd treatment to report to the hospital.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient needed to discontinue a ccpd treatment on (b)(6) 2023 due to weakness, dizziness, and malaise.The patient was safely disconnected from her liberty select cycler and transported to the emergency department by a family friend.The patient was admitted to the hospital on the same day after being diagnosed with pneumonia, attributed to the patient¿s pulmonary comorbidities.There was no indication of a causal relationship to pd therapy or cycler use.The patient has been able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) for the duration of the admission.The patient is recovering from this event while awaiting discharge home.It was confirmed that the patient¿s pneumonia and associated symptoms were unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue ccpd therapy on the same liberty select cycler at home upon discharge.
 
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.
 
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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 Key17049288
MDR Text Key316396397
Report Number0002937457-2023-00781
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 06/16/2023
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 05/26/2023
Initial Date FDA Received06/02/2023
Supplement Dates Manufacturer Received06/14/2023
Supplement Dates FDA Received06/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2019
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 Age68 YR
Patient SexFemale
Patient Weight128 KG
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