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

Catalog Number 190713

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A biomedical engineer (biomed) at a user facility reported that the fresenius 2008t hemodialysis (hd) machine had melted the plastic chamber causing smoke.The machine was in the back room undergoing a rinse cycle when the facility¿s smoke detector had alarmed.The building was evacuated by the staff.It was reported that smoke was visible in the back room coming from the machine and a burning smell was noticed but there was no report of fire or spark.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals as a result of this malfunction.All patients were able to complete treatment after returning to the building.Following the event, the machine was evaluated on-site at the user facility by a fresenius regional equipment specialist (res).The res identified three valves on the balancing chamber were corroded and valve #31 was shorted and burned a section of the balancing chamber.There was no damage identified to any of the machine boards or wires.The res replaced the balancing chamber module.Following the part replacement and subsequent safety checks by the biomed, the system was restored to full functionality.The unit was returned to service at the user facility without a recurrence of the event as reported.No parts have been made available to be returned to the manufacturer for physical evaluation at this time.

Manufacturer Narrative

Plant investigation: the 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res).The res identified three valves on the balancing chamber were corroded and valve #31 was shorted and burned a section of the balancing chamber.There was no damage identified to any of the machine boards or wires.The res replaced the balancing chamber module.Following the part replacement and subsequent safety checks by the biomed, the system was restored to full functionality.The unit was returned to service at the user facility without a recurrence of the event as reported.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 identified 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 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: 6985623
• MDR Text Key: 91100206
• Report Number: 2937457-2017-01099
• 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: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2013
• 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