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); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A biomedical technician (biomed) at the user facility reported that a 2008t hemodialysis (hd) machine had low flow error message in rinse mode.No patient was connected to the machine at the time of the incident.Therefore, no patient was involved.The biomed was unable to duplicate the flow errors.Subsequently, the machine powered down with audible alarm in dialysis mode.A burning smell was coming from the power supply.The biomed performed a visual assessment and found the rocker switch showing signs of heat.The biomed replaced the rocker switch to resolve the issue.The biomed observed a spark from the power supply.The bridge rectifier in the power supply had burn damage.The bridge rectifier was replaced to resolve the issue.The machine now gives a low temperature message in dialysis mode.Attempts to gather additional event related information have been unsuccessful.Therefore, the current repair status of the machine is unknown and it is not known if the unit has been returned to service at the user facility.The power rocker switch and the bridge rectifier are not available to be returned to the manufacturer for evaluation as they have been discarded by the user facility.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.An investigation of the device manufacturing records was conducted and verified that there were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, a device history records (dhr) review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and the complaint could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 6862756
• MDR Text Key: 86116552
• Report Number: 2937457-2017-00883
• 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: consumer,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• 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: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2013
• 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