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); Arcing (2583); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2019

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 user facility biomedical technician (biomed) reported that a fresenius 2008t machine had an arc after the metal in the power supply was crossed. The biomed stated that a spark was observed, and the power plugs were burned. There was no patient involvement during the event. There was no flame or smoke observed. The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components. The machine has approximately 28,000 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. There was no voltage, however there was voltage from the outlet. The biomed checked the 120vac and tried another outlet. The power supply, power logic board, the motherboard and the front panel keypad were replaced. After installing a replacement actuator board and mother board, the machine displayed the following message: "active pressure regulator not calibrated. " the biomed stated that the issue was resolved, and the machine has been returned to service without issue. The power plugs were reported to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: although it was stated that the complaint device was available to be returned, to date no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). 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 not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9157139
• MDR Text Key: 161233294
• Report Number: 2937457-2019-03119
• 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,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/04/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse