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

Catalog Number 190713

Device Problem Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user facility¿s biomedical technician reported that a 2008t hemodialysis (hd) machine had a charred power supply cord.No patient was connected to the machine at the time of the incident.A fresenius regional equipment specialist (res) performed an on-site evaluation of the unit.The res confirmed that the power supply wire was black.The res replaced the upper power supply assembly to resolve the issue.Functional testing performed by the res confirmed the system was operating properly.Follow-up was provided by the biomed who confirmed that no flames or sparks were observed, and no smoke was visible.Additionally, no melted parts were identified.The unit has been returned to service at the user facility without issue.No parts were available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res).The res confirmed that the power supply wire was black.The res replaced the upper power supply assembly to resolve the issue.Functional testing performed by the res confirmed the system was operating properly.The unit has been returned to service at the user facility without issue.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances or any associated rework during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was able to confirm the failure mode.A visual examination by the res revealed the presence of heat damage to the power supply wire.Therefore, the complaint has been deemed 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: 6606378
• MDR Text Key: 76509085
• Report Number: 2937457-2017-00417
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• 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