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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING UL LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Model Number LIBERTY CYCLER
Device Problems Overfill; Noise, Audible
Event Date 01/28/2018
Event Type  Injury  
Manufacturer Narrative

The device has not been returned to the manufacturer. A supplemental report will be filed upon completion of the manufacturer's investigation.

 
Event Description

A peritoneal dialysis patient's contact requested assistance in bypassing on the cycler. The contact stated that the patient had returned home from the hospital and was empty. It was also reported that the cycler was noisy during drains.

 
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Brand NameUL LIBERTY CYCLER
Type of DeviceSYSTEM, 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 Key7271542
Report Number2937457-2018-00468
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberLIBERTY CYCLER
Device Catalogue NumberRTLR180111
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age mo
Event Location Home
Date Manufacturer Received02/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/23/2011
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: 02/14/2018 Patient Sequence Number: 1
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