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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); Hypervolemia (2664)
Event Date 09/26/2023
Event Type  Injury  
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: based on the available information, there is no allegation or indication that a fresenius device or product issue caused or contributed to a serious patient harm or injury.Therefore, the completion of a clinical investigation is not warranted currently.
 
Event Description
On (b)(6) 2023, a call was placed to customer support requesting operation assistance with how to out the fresenius cycler into stat drain for this patient on peritoneal dialysis (pd).There were no reported issues with the device.Rather, it was stated the patient had to cancel the pd treatment to go to the emergency room.Through additional follow-up, it was stated by the patient¿s pd nurse that on (b)(6) 2023 the patient was admitted to the hospital for fluid volume overload characterized by shortness of breath.The patient received pd therapy while hospitalized and was subsequently discharged on (b)(6) 2023.The nurse confirmed the event was not related to any issues with the fresenius cycler.It was stated the fluid volume overload was due to the patient not using the correct strength pd solution for fluid removal needs.The patient continues pd on his home cycler without any reported adverse effects.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Complaint investigation did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.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) 2023 a call was placed to customer support requesting operation assistance with how to out the fresenius cycler into stat drain for this patient on peritoneal dialysis (pd).There were no reported issues with the device.Rather, it was stated the patient had to cancel the pd treatment to go to the emergency room.Through additional follow-up, it was stated by the patient¿s pd nurse that on (b)(6) 2023 the patient was admitted to the hospital for fluid volume overload characterized by shortness of breath.The patient received pd therapy while hospitalized and was subsequently discharged on (b)(6) 2023.The nurse confirmed the event was not related to any issues with the fresenius cycler.It was stated the fluid volume overload was due to the patient not using the correct strength pd solution for fluid removal needs.The patient continues pd on his home cycler without any reported adverse effects.
 
Event Description
On (b)(6) 2023, a call was placed to customer support requesting operation assistance with how to out the fresenius cycler into stat drain for this patient on peritoneal dialysis (pd).There were no reported issues with the device.Rather, it was stated the patient had to cancel the pd treatment to go to the emergency room.Through additional follow-up, it was stated by the patient¿s pd nurse that on (b)(6) 2023 the patient was admitted to the hospital for fluid volume overload characterized by shortness of breath.The patient received pd therapy while hospitalized and was subsequently discharged on (b)(6) 2023.The nurse confirmed the event was not related to any issues with the fresenius cycler.It was stated the fluid volume overload was due to the patient not using the correct strength pd solution for fluid removal needs.The patient continues pd on his home cycler without any reported adverse effects.
 
Manufacturer Narrative
Correction: a1.
 
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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 Key17941033
MDR Text Key325750007
Report Number0002937457-2023-01563
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,Followup
Report Date 12/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2023
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 Received12/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2020
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
LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; PD SOLUTION; PD SOLUTION; PD SOLUTION
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
Patient SexMale
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