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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 12/03/2022
Event Type  Injury  
Event Description
On (b)(6) 2022 a peritoneal dialysis (pd) patient contacted fresenius technical support.The patient reported that they were currently in the hospital, and it was pd related.Follow-up with the patient was conducted which documented that the patient went to the hospital on (b)(6) 2022 due to shortness of breath.The patient was admitted with a diagnosis of fluid retention.The patient confirmed they were not in active treatment at the time of experiencing the symptoms of shortness of breath.The patient was discharged on (b)(6) 2022.The patient has recovered and continues to complete pd therapy.No further information was provided.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is a possible temporal relationship between the patient¿s adverse event of shortness of breath due to fluid retention and subsequent hospitalization and use of the liberty select cycler; however, the patient was not in treatment at the time of the event and the cause of the fluid retention is unknown.There is no documentation in the complaint file to show a causal relationship between the patient¿s adverse event and use of the liberty select cycler.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.Fluid retention manifests as fluid overload in dialysis patients which may reflect any combination of inappropriate prescription, noncompliance, loss of residual renal function, mechanical problems, and peritoneal membrane dysfunction.Additionally, non-compliance to dietary restrictions can contribute to fluid volume status in patients.Based on the limited information and no allegation or evidence of a device malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patient¿s hospitalization for fluid retention preceded by shortness of breath.
 
Manufacturer Narrative
Correction: h6.
 
Event Description
On (b)(6) 2022 a peritoneal dialysis (pd) patient contacted fresenius technical support.The patient reported that they were currently in the hospital, and it was pd related.Follow-up with the patient was conducted which documented that the patient went to the hospital on (b)(6) 2022 due to shortness of breath.The patient was admitted with a diagnosis of fluid retention.The patient confirmed they were not in active treatment at the time of experiencing the symptoms of shortness of breath.The patient was discharged on (b)(6) 2022.The patient has recovered and continues to complete pd therapy.No further information was provided.
 
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 a peritoneal dialysis (pd) patient contacted fresenius technical support.The patient reported that they were currently in the hospital, and it was pd related.Follow-up with the patient was conducted which documented that the patient went to the hospital on (b)(6) 2022 due to shortness of breath.The patient was admitted with a diagnosis of fluid retention.The patient confirmed they were not in active treatment at the time of experiencing the symptoms of shortness of breath.The patient was discharged on (b)(6) 2022.The patient has recovered and continues to complete pd therapy.No further information was provided.
 
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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 Key16034984
MDR Text Key306005978
Report Number0002937457-2022-02187
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/17/2023
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 12/05/2022
Initial Date FDA Received12/22/2022
Supplement Dates Manufacturer Received12/23/2022
01/17/2023
Supplement Dates FDA Received01/04/2023
01/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET 
Patient Outcome(s) Hospitalization;
Patient SexFemale
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