• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number RTLR180343
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 05/06/2019
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 peritoneal dialysis registered nurse (pdrn) reported that a peritoneal dialysis patient was training on the cycler and the screen went blank.The pdrn also reported that smoke was observed from the cycler.The patient¿s treatment was canceled.The ok and stop keys were on, however the screen remained blank.The outlet was working.The pdrn was advised to discontinue the use of the cycler.Upon follow up, the peritoneal dialysis nurse (pdrn) stated the patient was not connected when the event occurred.The pdrn stated that there was no fire or spark observed.The pdrn stated that a burning smell and smoke emitted from the cycler.A replacement was received, and old cycler was returned to the manufacturer for physical evaluation.
 
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.An internal inspection of the cycler found evidence of an internal short present on transformer (t1) of the inverter board.The inverter board is located on the rear of the front panel assembly.A known good inverter board was installed, and the touch screen became operational.Removed functioning inverter board from the touch screen at the completion of the investigation.During the internal inspection there was no evidence of smoke.There were no other discrepancies encountered in the internal inspection of the cycler.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 an internal short on the inverter board.The cycler was refurbished following the evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Type of Device
SYSTEM, 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 Key8607482
MDR Text Key144954478
Report Number2937457-2019-01468
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861102068
UDI-Public00840861102068
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 company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 07/16/2019
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 Manufacturer06/26/2019
Is the Reporter a Health Professional? Yes
Device Age MO
Initial Date Manufacturer Received 05/06/2019
Initial Date FDA Received05/14/2019
Supplement Dates Manufacturer Received07/10/2019
Supplement Dates FDA Received07/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-