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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 Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A biomedical technician (bmt) reported that a power cord socket is broken and power cord is bent at the socket.A staff member attempted to power on the cycler but sparks occurred at the socket.Power switch is partially pushed into the cycler.The cycler cannot be powered on.The technical services issued a new cycler.In a follow up, the bmt said there was no patient involved and there was no harm or adverse event due to the sparks.The cycler is available to be returned for investigation.
 
Event Description
A biomedical technician (bmt) reported that a power cord socket is broken and power cord is bent at the socket.A staff member attempted to power on the cycler but sparks occurred at the socket.Power switch is partially pushed into the cycler.The cycler cannot be powered on.The technical services issued a new cycler.In a follow up, the bmt said there was no patient involved and there was no harm or adverse event due to the sparks.The cycler is available to be returned for investigation.
 
Manufacturer Narrative
Additional information: d.9.,h.3.Plant investigation: the actual device was returned to the manufacturer for physical analysis.A visual inspection of the returned cycler exterior showed signs of physical damage to the power entry module, and a faded top cover label.There were no visual indications of dried fluid within the cassette compartment on the pump.There were no visual indication of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The voltage verification check failed.Due to the physical damage on the power entry module the cycler was not able to power on.The power entry module was replaced to continue testing.The as-received simulated treatment with a reduced dwell time was performed and completed.The valve actuation test passed.The system air leak test passed.The patient sensor check passed.There were visual indications of dried fluid on the bottom cover underneath the pump assembly.The cause of the observed dried fluid could not be determined.There were no discrepancies encountered with the mushroom heads.The device history record did not reveal any issues or problems related to the reported symptom code(s).Upon completion of the evaluation, there were no malfunctions that confirmed the reported event of sparks.A cause could not be determined.The cause of the reported sparks cannot be confirmed.
 
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Brand Name
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key18700342
MDR Text Key336414870
Report Number0002937457-2024-00257
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? Yes
Device AgeMO
Date Manufacturer Received01/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2012
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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