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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY / FKX

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CONCORD MANUFACTURING LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY / FKX Back to Search Results
Catalog Number RTLR180111
Device Problem Incorrect, Inadequate or Imprecise Result or Readings
Event Date 10/03/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). The clinical review of this report could not rule out a possible association between the liberty cycler and the event of fluid overload. However, there is also a possible association between the patients' reported noncompliance with monitoring of blood sugar, vital signs and medication adherence, which would have significant impact on the event of fluid overload. A supplemental report will be submitted upon completion of the plant investigation.

 
Event Description

A registered nurse (rn) reported that a peritoneal dialysis (pd) patient using the liberty cycler was not draining correctly. According to the rn, this patient who has been on peritoneal dialysis (pd) since (b)(6) 2015 went to the hospital on (b)(6) 2016 for fluid overload and received medical intervention (not specified). Upon follow up it was determined that the patient was discharged from the hospital to home within 24 hours and resumed manual pd treatment until the arrival of a replacement liberty cycler. As per the rn, as of (b)(6) 2016 the replacement liberty cycler had been received and in use by without any further reported issue. Medical records show the patient called to request dialysis solution of 4. 25% dextrose (this solution is more hyperosmotic and used to increase ultrafiltration and net fluid removal) be added to his delivery as he is retaining fluid in his lower extremities. The rn asked the patient what his blood sugar reading was for the day. The patient responded he had not taken it yet. The rn reminded patient to take vitals and blood sugar every day and document the results in the machine. During a call with the rn, she had revealed that the patient is not always compliant with monitoring his blood sugar, vital signs or with taking his medications (medication patient takes was not indicated).

 
Manufacturer Narrative

The cycler was returned for evaluation. The visual internal inspection of the cycler found evidence of dried fluid within the recess of the bottom cover adjacent to the pump. The simulated treatment was performed and completed without any alarms or problems occurring. There were no fluid leaks in the test cassettes during the treatment tests. The valve actuation test passed. The system air leak test passed. The patient sensor calibration check passed. The load cell value and verification was within tolerance. There were indications of dried fluid within the recess of the bottom cover adjacent to the pump and cassette area. The cause of the encountered dried fluid could not be determined. The cycler passed the mushroom head checks. In addition, the device record review confirmed the labeling, material, and process controls were within specification.

 
Event Description

Upon additional follow up for an unrelated event for the patient, the nurse reported that the patient had the fluid removed while in the hospital and then used continuous ambulatory peritoneal dialysis (capd) at home. The rn stated that the patient had gone to the clinic for his monthly visit and he was doing well.

 
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Brand NameLIBERTY CYCLER
Type of DeviceSYSTEM, PERITONEAL, AUTOMATIC DELIVERY / FKX
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 Key6069874
Report Number2937457-2016-01129
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER,USE
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue NumberRTLR180111
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age mo
Event Location No Information
Date Manufacturer Received11/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/18/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/01/2016 Patient Sequence Number: 1
Treatment
LIBERTY CYCLER CASSETTE
PD FLUID
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