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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 Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2024
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A peritoneal dialysis (pd) patient reported that there was a fluid leak during pd treatment.When the cassette was removed there was fluid on the sensor.In a follow up, a pd nurse verified the event and said the fluid was discovered upon treatment completion when the patient was removing the cycler set from the cassette compartment of the liberty select cycler.The patient inspected the cycler set.No defect or damage was noted.The nurse stated that the patient was prescribed prophylactic antibiotic ciprofloxacin (250 mg, oral, three times daily for three days).The pd nurse confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.Nurse confirmed the cycler remained with the patient for continued use.The patient dried out the cassette compartment of the cycler and planned to continue using.
 
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 peritoneal dialysis (pd) patient reported that there was a fluid leak during pd treatment.When the cassette was removed there was fluid on the sensor.In a follow up, a pd nurse verified the event and said the fluid was discovered upon treatment completion when the patient was removing the cycler set from the cassette compartment of the liberty select cycler.The patient inspected the cycler set.No defect or damage was noted.The nurse stated that the patient was prescribed prophylactic antibiotic ciprofloxacin (250 mg, oral, three times daily for three days).The pd nurse confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.Nurse confirmed the cycler remained with the patient for continued use.The patient dried out the cassette compartment of the cycler and planned to continue using.
 
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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 Key19003801
MDR Text Key339046004
Report Number0002937457-2024-00536
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
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received03/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2013
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 Age57 YR
Patient SexMale
Patient Weight107 KG
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