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

Catalog Number RTLR180111

Device Problems Moisture Damage (1405); Smoking (1585); Environmental Compatibility Problem (2929)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2017

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient contact reported that the patient¿s cycler kept powering on and off and had a burning smell on power-up.The cycler is plugged into a three-prong outlet directly into the wall and the power cord is secure on both ends.When the iqdrive was removed from the cycler, it was wet due to water damage from flooding from the hurricane in the area.Follow-up information with the patient revealed that the cycler had a burning smell and smoke due to being wet from flooding.There was no fire and no patient injury or adverse reaction.The patient was able to complete treatment using manual therapy.The patient¿s cycler and iqdrive are to be replaced.

Manufacturer Narrative

The cycler was returned to the manufacturer for evaluation.A visual inspection of the exterior showed no signs of physical damage.The device was unable to be powered on.During examination, the issue was found to be that the cycler power supply module output voltage was 0 volts.After the power supply module was replaced, the cycler was able to turn on and was subjected to a simulated treatment test.The simulated treatment was performed and completed without any failures.There were no unusual odors observed during testing.The voltage check passed.An internal inspection of the cycler found no discrepancies.The power supply module that had to be replaced showed that the in-circuit fuse had blown.In addition, the c8 electrolytic capacitor in the power supply module was bulging and there was an observed oily, brownish film on the bracket underneath the power supply module.An investigation of the device history (dhr) records was conducted by the manufacturer.There were no issues found during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control testing met all requirements.The investigation into the cause of the reported incident was able to be confirmed.Although the evaluation of the returned device could not duplicate burning smell or smoke, it was confirmed that the cycler could not function properly as the capacitor on the power supply module had failed.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(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; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6882195
• MDR Text Key: 87645233
• Report Number: 2937457-2017-00931
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1