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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pneumonia (2011); Cramp(s) (2193); Abdominal Distention (2601)
Event Date 05/10/2018
Event Type  Injury  
Manufacturer Narrative
There is no documentation in the complaint file to show a causal relationship between the patient event of pneumonia with subsequent hospitalization and the liberty cycler.Additionally, there is no evidence or documentation that shows the patient experienced a peritoneal tear at any time.There is a temporal relationship between the patient feeling full and cramping and pd therapy on the liberty cycler.Treatment data did not document any overfill during the patient¿s pd therapy.A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
On (b)(6) 2018 this female patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support to report that she felt like the liberty cycler was overfilling her.The patient stated she felt full and cramping throughout the treatment.The treatment data including alarm history was reviewed and there was no overfill documented.The patient also stated that they just got out of the hospital due to a peritoneal tear caused by the liberty cycler.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) on may 11, 16 and 22.Per the pdrn, they are unaware of any hospitalization due to a peritoneal tear.The patient was recently hospitalized (date unknown) due to a diagnosis of community acquired pneumonia which was unrelated to pd therapy.Hospital course is unknown and unknown if any fresenius products were used during the hospitalization.The patient was last seen in the pd clinic on (b)(6) 2018 and was doing well with no reported issues.Additional information was solicited.
 
Manufacturer Narrative
The simulated treatment was performed, completed without failure therefore the reported symptom alarm (unknown) and non-operational questions were not confirmed.The reported symptom no allegation of product deficiency was not confirmed.The simulated treatment was performed, completed without failure.Passed mushroom head check.Test negative for glucose.The system air leak passed.The voltage check passed.A visual inspection of the returned cycler exterior showed no sign of physical damage.There was presence of yellowish discoloration on internal tubes within cycler.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The cause of the observed yellowish discoloration could not be determined.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.
 
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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
MDR Report Key7553337
MDR Text Key109577975
Report Number2937457-2018-01497
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861100972
UDI-Public00840861100972
Combination Product (y/n)N
PMA/PMN Number
K123630
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 06/06/2018
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 NumberLIBERTY CYCLER
Device Catalogue NumberRTLR180111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
Device AgeMO
Initial Date Manufacturer Received 05/10/2018
Initial Date FDA Received05/30/2018
Supplement Dates Manufacturer Received06/05/2018
Supplement Dates FDA Received06/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LIBERTY CYCLER SET; PD SOLUTION; LIBERTY CYCLER SET; PD SOLUTION
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age41 YR
Patient Weight60
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