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)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2019

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 a user facility reported that a fresenius 2008t hemodialysis (hd) machine powered off by itself in rinse mode and had a burning smell.The machine had a charred and melted actuator board.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The actuator board and power logic board were replaced, which resolved the issue.The unit was returned to service at the user facility.

Manufacturer Narrative

Plant investigation: the power logic board and actuator board was returned to the manufacturer for physical evaluation.A visual inspection of the returned part showed no sign of physical damage.The received power logic board was installed onto a test machine.The machine powered on with a fail long pulse failure code.The failure was due to a shorted transistor (t4).The t4 was replaced with a known good transistor and a self-test was performed.There were no alarms or issues encountered during power up and the self-test passed without any issue or problem.The actuator board was returned and a visual inspection revealed a damaged j1 connected.The received actuator board was installed into a test machine.The test machine failed to power on.The failure was due to shorted capacitors and ic chip (c96, 95, and ic18).Tracing damaged was encountered.The tracing damage was due to shorted components and was unable to be repaired.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 related to 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.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be an internal shorts on components on the power logic board and actuator board.The cycler was refurbished following the evaluation.

• 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
• MDR Report Key: 8930949
• MDR Text Key: 155517677
• Report Number: 2937457-2019-02707
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• 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: 08/15/2019
• Device Age: MO
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1