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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING LIBERTY SELECT CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number RTLR180343
Device Problems Thermal Decomposition of Device (1071); Charred (1086); Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2018
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.Upon turning on the cycler, the display was dim at the maximum brightness setting.An internal inspection of the cycler identified that the cause for the display issue was due to a burnt j2 connector on the inverter board that connects to the display.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 of a burning smell and dimmed display was confirmed and the cause was determined to be a faulty inverter board with a burnt j2 connector.The cycler was refurbished following the evaluation and the inverter board was replaced.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the screen of a patient¿s liberty cycler began to dim during drain three of four of the patient¿s peritoneal dialysis therapy.The patient had drained 505ml of an expected 1800ml at the time of the event.It was noted that as the display began to dim, there was a burning smell coming from the cycler.The cycler was plugged directly into a power outlet and there had not been any recent power outages at that location.The technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse of the event.The patient had manual supplies to continue their treatment without the cycler.The cycler was returned to the manufacture.Upon evaluation, it was identified that the j2 connector that goes to the display was burnt.The inverter board was replaced as a result of the damage.At this point in time, there has been no report of patient injury or medical intervention required as a result of the event.Additional information was requested but was unavailable.
 
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Brand Name
LIBERTY SELECT CYCLER
Type of Device
SYSTEM, 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 Key7306316
MDR Text Key101478860
Report Number2937457-2018-00637
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861102068
UDI-Public00840861102068
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Patient
Type of Report Initial
Report Date 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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 Manufacturer02/14/2018
Is the Reporter a Health Professional? No
Device AgeMO
Initial Date Manufacturer Received 02/28/2018
Initial Date FDA Received03/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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