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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Model Number LIBERTY CYCLER
Device Problems Sparking; Power Problem; Appropriate Term/Code Not Available
Event Date 08/01/2017
Event Type  Malfunction  
Manufacturer Narrative

The device was returned for evaluation. The investigation confirmed the following: the exterior visual inspection showed no signs of physical damage, discoloration or discrepancies. The voltage check passed. There were no discrepancies encountered in the internal inspection of the cycler. There were no abnormal or unusual smells observed upon conclusion of testing. The device did not power down during testing. The device operated within specification.

 
Event Description

A peritoneal dialysis patient reported that the cycler powered down the previous evening and smells like burning. The patient stated that the cycler sparks at the back. The patient discontinued use and performed manual treatment. The patient received a replacement cycler and has successfully been completing treatments. There has been no patient injury or adverse event.

 
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Brand NameLIBERTY 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 Key6830146
Report Number2937457-2017-00798
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberLIBERTY CYCLER
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/23/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age mo
Event Location Home
Date Manufacturer Received08/01/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/31/2016
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: 08/30/2017 Patient Sequence Number: 1
Treatment
LIBERTY CYCLER SET
PD FLUID
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