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

Model Number 190713

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2020

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 user facility biomedical technician (biomed) reported no conductivity on a fresenius 2008t hemodialysis (hd) machine.Per the biomed, the acid pump is pink on the debug zero and the machine is also making a cracking noise.A fresenius fst (field service technician) was called onsite by the user facility to repair the 2008t machine with a noisy acid pump, low conductivity, and a reported 'acid pump no eos' alarm.The fst replaced the acid pump and the actuator test board to resolve the reported issue.Per the information in the service confirmation report, the machine issue has been resolved, the machine has passed functional testing, and the machine has been returned to service.There is no report of patient involvement.A picture of the faulty actuator test board was provided and upon inspection of the picture, visible burn damage was noted.

Manufacturer Narrative

Additional information: device evaluated by mfr: plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the acid pump and the actuator test board.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.The investigation into the cause of the reported problem was able to confirm the reported failure mode.In addition, a review of the provided photograph of the actuator test board confirmed burn damage was present.Therefore, the complaint event was confirmed.

Manufacturer Narrative

Plant investigation: the actuator test board was not returned to the manufacturer for physical evaluation.However, the acid bicarb pump was returned.The reported failures associated with the pump could not be duplicated.Those failures, a noisy acid pump, low conductivity, and an acid pump no end of stroke (eos) message, were not confirmed.The acid bicarb pump was received with no signs of physical damage.The part was installed onto a test machine to test for the reported failures.There were no problems during the initial power up.After powered on, a rinse program was completed without problems, dialysis mode functioned properly without any alarms, and the conductivity was stable at 13.5 ms/cm.The self-test program was then completed without failures.During testing, there were no unusual noises noted.The test machine performed as designed and an associated cause could not be determined.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10865425
• MDR Text Key: 217058694
• Report Number: 2937457-2020-02093
• 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,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Device Age: MO
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1