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

Model Number 2008T

Device Problems Thermal Decomposition of Device (1071); Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2017

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 biomedical technician at the user facility reported that a 2008t hemodialysis (hd) machine failed the 9 volt battery test during its self test.The biomed swapped the 9 volt battery with a known good one, however, while inspecting the unit, the ic9 chipset on the power logic board was found to be burnt.Follow-up was provided which revealed that no smoke was observed, and no flames or sparks were visible.No patient was connected to the machine at the time of the incident as the issue was observed while the unit underwent a self test.A replacement power logic board has been ordered, but has not been received.Therefore, the current repair status of the system is not known.

Manufacturer Narrative

Manufacturer evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.Follow-up was provided by the biomedical technician who revealed that burn damage was present on the ic9 chipset of the power logic board.The biomed replaced the power logic board to resolve the issue.The unit has been 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 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

Follow-up was provided by the biomedical technician who revealed that the new power logic board was received, and then the 2008t hemodialysis machine was repaired by installing the replacement board.The unit has been returned to service at the user facility without a recurrence of the event as reported.

• 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: 6530112
• MDR Text Key: 74064512
• Report Number: 2937457-2017-00303
• Device Sequence Number: 1
• Product Code: KDI
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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
• Other Device ID Number: 00840861100897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2015
• 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