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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number RTLR180343
Device Problem Thermal Decomposition of Device
Event Date 03/31/2019
Event Type  Malfunction  
Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation. An exterior visual inspection of the returned cycler showed no signs of physical damage. Upon power up, the cycler touch screen test failed. When powering on the cycler, the ok, stop and up/down arrow push buttons illuminated; however, the front panel touch screen remained blank. It was identified that the cause for the blank screen was due to a burnt transformer (t1) on the inverter board. The inverter board is located on the rear of the touch screen. A known good inverter board was installed, and the display became fully operational. The cycler underwent and passed a system air leak test, valve actuation test and mushroom head check. The pre- accelerated stress test (ast) 15 min 1000 ml simulated treatment was performed and completed without failures. Visual evidence of dried fluid was found within the recess of the bottom cover adjacent to the pump during the internal inspection of the cycler. The cause the observed dried fluid could not be determined. The cycler tested positive for glucose. An internal visual inspection of the returned cycler encountered no other discrepancies. A review of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements. Upon completion of the evaluation, the reported issue was confirmed, and the cause was determined to be a burnt transformer on the inverter board. The cycler was refurbished following the evaluation.

 
Event Description

It was reported that the screen of a patient¿s liberty select cycler went blank during an unknown phase their peritoneal dialysis (pd) treatment. The wall outlet was working. The ok and stop keys were on and the cycler was rebooted; however, the screen remained blank. At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event. A replacement cycler was issued to the patient. It was reported that an alternate treatment option was not available. Upon follow up, the patient confirmed that there were no adverse events or medical intervention required as a result of the reported event. The patient completed treatment using manuals. The cycler was returned to the manufacturer and a replacement cycler was provided and received. Upon physical evaluation of the cycler by the manufacturer, it was identified that the transformer on the inverter board was burned.

 
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Brand NameLIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Type of DeviceSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st.
waltham , MA 02451
7816999758
MDR Report Key8564669
Report Number2937457-2019-01258
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 04/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2019
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberRTLR180343
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/08/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Device Age mo
Event Location No Information
Date Manufacturer Received04/26/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/21/2017
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: 04/30/2019 Patient Sequence Number: 1
Treatment
DELFLEX PD FLUID
LIBERTY CYCLER SET 
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