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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 Problem Appropriate Term/Code Not Available
Event Date 07/30/2017
Event Type  Injury  
Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed. However, an investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure. A device is not released if it does not meet requirements or is nonconforming. In addition, the device record review confirmed the labeling, material, and process controls were within specification.

 
Event Description

A medical support specialist reported that a peritoneal dialysis patient did not receive a replacement cycler and was subsequently admitted to the hospital. The patient came to clinic to borrow clinic cycler and patient was symptomatic and sent to er for weakness and chest pain. Additionally, per the patient's nurse, the patient presented to the hospital with a potassium level of 6. 5 meq/l. The patient was dialyzed at the hospital and discharged. The patient has since received a replacement cycler and successfully completing treatments.

 
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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 Key6828480
Report Number2937457-2017-00806
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 10/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
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 Received09/13/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/29/2017 Patient Sequence Number: 1
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