MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191126

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

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 entire power supply. 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. During the device evaluation, the fresenius fst identified evidence of charring and melting on the machine's power plug. Therefore, the complaint event was confirmed.

Event Description

A user facility biomedical technician (biomed) reported that a fresenius 2008t machine powered down unexpectedly during the setup for a hemodialysis (hd) treatment. The machine operator performed a quick inspection of the device and noticed the power plug looked burnt and was hot to the touch. The machine was pulled from service for further examination and a fresenius field service technician (fst) was called onsite to perform an evaluation. During the evaluation, the fst reportedly found evidence of charring and melting on the power plug. Photos of the power plug were provided by the fst, and they validated the reported damage. One of the photos showed black residue which looks like it melted (from the power plug) and seeped into the power outlet, as described by the fst. The outlet was removed from the wall and replaced before the fst arrived at the unit. There was no smoke, burning smell, or arcing reported. Additionally, there were no reported sparks or flames. No other damaged components or parts were found. The fst stated the clinic does not utilize hospital grade ground-fault interrupter (gfci) outlets. It was recommended that they transition to this type of outlet. The fst also advised them to call an electrician onsite to evaluate the unit¿s electrical wiring. Upon follow up with the unit¿s biomed, it was confirmed that the machine had no previous history of failing the electrical leakage test. The fst replaced the entire power supply to resolve the reported issue. After the repair was completed, machine functional tests were performed, and they passed. The machine was subsequently returned to service. There was no patient involvement associated with the reported event. The fst stated the damaged power plug was available to be returned for evaluation, but to date, it has not been received by the manufacturer.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• 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
• 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: 9673844
• MDR Text Key: 177882509
• Report Number: 2937457-2020-00251
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• 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: 04/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/05/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse