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); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the reported problem that diode d17 ¿ohmed out too low¿ was confirmed during the investigation of the returned power control board.Diode d17 measured short.The reported problem that the "machine would not power on¿ was not confirmed as a test machine powered up without alarm or failure with the complaint power control board installed.The complaint power control board was replaced in the test machine with the machine¿s power control board prior to testing the complaint power logic board.The reported ¿low temperature¿ problem was also not confirmed during the investigation of the complaint power logic board.The test machine gave a ¿heater relay test fail¿ alarm when the machine was placed into dialysis with the power logic board installed.Transistor t5 was observed to have burn damage and was measured to be shorted.After replacing t5, the test machine completed a self-test program without alarm or failure.A shorted diode d17 on the power control board is known to cause the failure of transistor t5 on the power logic board.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A user facility biomedical engineer (biomed tech) reported the hemodialysis dialysis machine had no power and low temperature.A fresenius regional equipment specialist technician replaced the power control board and the power logic board to resolve the issues.The machine passed all functional checks (fc) and the machine was cleared to return to service.The service confirmation indicated no patient was involved with this issue.During the investigation it was discovered the transistor t5 was observed to have burn damage and was measured to be shorted.

• 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: 7377781
• MDR Text Key: 103732164
• Report Number: 2937457-2018-00893
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• 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