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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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CONCORD MANUFACTURING UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Model Number LIBERTY CYCLER
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2018
Event Type  malfunction  
Manufacturer Narrative
The reported symptom (iipv ((dv > 200% of fv) was not confirmed.The reported symptom balloon valve leak warning was not confirmed.Encountered dc drain complication encountered.There was visual evidence of liquid within pneumatic filter hp1.The hp1 filter was replaced.After replaced the clogged hp1 the simulated treatment was performed, completed without any failures or problems.The cycler weighed fill volume values were within tolerance.The system air leak passed.The voltage check passed.The load cell value and verification was within tolerance.A visual inspection of the returned cycler exterior showed no sign of physical damage.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
 
Event Description
Peritoneal dialysis patient contact reported during troubleshooting with technical support that the patient experienced high drain volumes.Patient treatment data was provided and assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv).The largest drain volume from this treatment occurred during drain 4 where 4499ml drained.This drain is 214% of the prescribed fill volume.In order to be a reportable malfunction, at least 180% of the prescribed fill volume would have to have been drained.180% of the prescribed fill volume of 2106ml is 3791ml.Therefore, a reportable malfunction has occurred.The patient was advised to cancel treatment and to contact the clinic nurse.The liberty cycler was replaced.Additional information was solicited.
 
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Brand Name
UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7500655
MDR Text Key107828722
Report Number2937457-2018-01292
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861100972
UDI-Public00840861100972
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123630
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberLIBERTY CYCLER
Device Catalogue NumberRTLR180111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Is the Reporter a Health Professional? No
Device AgeMO
Initial Date Manufacturer Received 04/19/2018
Initial Date FDA Received05/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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