MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008T

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Dialysis clinic biomed engineer reported that upon inspection of the liberty cycler, the power cord prongs appeared to be melted.Follow-up with the biomed engineer indicated that the clinic nurse initially observed the melted cord between patient treatments.There was no observation of smoke, spark, or flame when the melted cord prong was observed.There was no patient involvement.

Manufacturer Narrative

The alleged event was not confirmed by the plant.The complaint sample was not returned to the plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

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Manufacturer Narrative

The device was received at the manufacturing plant and the alleged event is confirmed.The power cord was received with heat damage on the prong (neutral side) of the plug.The plastic housing surrounding the neutral prong appears to be melted, however, no burning smell can be detected on the plug.There are signs of arcing and pitting on both sides of the prong (neutral).There are no other heat damage on the hot and ground side of the plug and no damages along the cord.Measurements were taking on each wires of the power cord which have continuity and the resistance between the wires are open as expected.The power cord was installed onto a test machine and plugged into an outlet which was tight and cannot be easily unplugged.The test machine powered on and a self-test was completed without failures.There were no additional damage nor burning smell on the plug during testing.The reported physical damage on the power cord is confirmed.The reported burning smell could not be confirmed.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 7130751
• MDR Text Key: 96020734
• Report Number: 2937457-2017-01369
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2008T
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• 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