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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
Catalog Number RTLR180111
Device Problems Incorrect, Inadequate or Imprecise Result or Readings; Device Issue; Device Operates Differently Than Expected
Event Date 10/04/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). The medical records did not reveal any allegation against fresenius products. The patient¿s nurse reported the pleural effusion was due to pd treatment. The pleural effusion was probably related to peritoneal dialysis using fresenius products. The pleural fluid glucose result suggests there was peritoneal dialysis fluid in the pleural space. A follow up will be submitted following plant evaluation.

 
Event Description

A peritoneal dialysis (pd) patient called technical services stating the cycler was not draining him completely. He stated that when he spoke with his nurse they thought he was absorbing the fluid and that is why his legs were swollen. His treatment record for (b)(6) 2016 did not show any overfills. During follow up with the patient¿s nurse she reported the patient had experienced a pleural effusion due to a diaphragm leak along with fluid overload. She reported the pleural effusion was due to pd therapy. The patient was not hospitalized for the event. The following is from medical records provided by the patient¿s treatment facility. The patient presented to clinic complaining of a right side, lower chest upper abdomen atypical pain. He was also complaining of low grade fever with t max of 99f.

 
Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation. However, an investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

 
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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 Key6138846
Report Number2937457-2016-01196
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 01/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2016
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? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age mo
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/03/2009
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: 12/01/2016 Patient Sequence Number: 1
Treatment
DELFLEX PD SOLUTION
LIBERTY TUBING
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