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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 Abdominal Pain (1685); Hernia (2240)
Event Date 06/26/2022
Event Type  Injury  
Event Description
A patient contact reported to fresenius this peritoneal dialysis (pd) patient was hospitalized for a stomach ache and hernia.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Multiple attempts were made to acquire further details concerning this patient¿s stomach pain, hernia and associated hospitalization; however, no additional information was obtained.In the intake, the patient contact reported this patient was hospitalized on (b)(6) 2022 for a stomach ache and hernia; however, it was also stated the hospitalization was unrelated to pd therapy.The patient was scheduled to undergo a procedure to ¿resolve the issue¿, presumably during this hospitalization.Patient demographics, causality of the patient¿s stomach pain and hernia, the reason for procedure, hospital discharge date, current disposition and any direct or indirect relationship these events have to the use of any fresenius product(s) or device(s) remain unknown.Presently there is no allegation or objective evidence indicating a serious injury, patient death, or other adverse event(s) occurred related to a fresenius product(s) or device(s).Additionally, there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s hernia, stomach pain and hospitalization.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: it is unknown if a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the adverse event of the patient¿s hernia and stomach pain, as the date and timing of these events are unknown.It is well established for those patients undergoing pd therapy are at high risk for mechanical complication due to hernias of any etiology and may be safely repaired to continue successful pd therapy.The cause of this patient¿s hernia cannot be determined; however, it was confirmed by a patient contact this event was unrelated to pd therapy.Regardless of this statement, the root cause of the patient¿s stomach pain and hernia remain unknown.Though the source of the patient¿s hernia is undetermined, it is well known most hernias occur prior to the start of pd therapy.In the absence of the additional required information, the liberty select cycler cannot be excluded as a potential source or contributor to this patient¿s adverse events.Based on the available information, there was no allegation or objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.
 
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
A patient contact reported to fresenius this peritoneal dialysis (pd) patient was hospitalized for a stomach ache and hernia.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Multiple attempts were made to acquire further details concerning this patient¿s stomach pain, hernia and associated hospitalization; however, no additional information was obtained.In the intake, the patient contact reported this patient was hospitalized on (b)(6) 2022 for a stomach ache and hernia; however, it was also stated the hospitalization was unrelated to pd therapy.The patient was scheduled to undergo a procedure to ¿resolve the issue¿, presumably during this hospitalization.Patient demographics, causality of the patient¿s stomach pain and hernia, the reason for procedure, hospital discharge date, current disposition and any direct or indirect relationship these events have to the use of any fresenius product(s) or device(s) remain unknown.Presently there is no allegation or objective evidence indicating a serious injury, patient death, or other adverse event(s) occurred related to a fresenius product(s) or device(s).Additionally, there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s hernia, stomach pain and hospitalization.
 
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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 Key14958726
MDR Text Key295512066
Report Number0002937457-2022-01141
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
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2022
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
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2015
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;
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