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 Problem Arcing (2583)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2019

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 2008t machine experienced a valve 104/108 stuck closed alarm.The machine was pulled from service and a fresenius field service technician (fst) was called onsite to perform an evaluation of the machine.During the evaluation, the fst reportedly found signs of arcing on the bibag distribution board.The fst ordered a part to repair the machine and then left the facility.By the time the fst returned to the facility with the replacement part in hand, the machine had already been returned to service.Upon follow up, the biomed stated the machine was no longer experiencing any issues and was therefore returned to service.The biomed stated there were no parts replaced or calibrated.It was confirmed that the machine stays plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed was unsure if the machine had a previous history failing the electrical leakage test.The machine was in service at the time of follow up and reported to be fully operational.Upon follow up with the fst, it was reported that ¿black streaks¿ were noted on the bibag distribution board.The fst stated the black streaks are indicative of arcing.The black streaks were present on the component where the ribbon cable and pins connect to the board.Photographs of the black streaks were requested, but none were taken.There was no reported smoke, sparks, flames or burning smell.The fst confirmed the machine had been returned to service prior to repairing it and verified with the biomed that there have been no further issues.The fst surmised that the circuit board got wet, leaving behind evidence of arcing in the form of black streaks.There was no patient involvement associated with the reported event.

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).During the evaluation, the fst confirmed finding signs of arcing on the bibag distribution 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.The fst identified evidence of arcing in the form of black streaks which were present on an internal machine component.Therefore, the complaint event was confirmed.

• 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
• MDR Report Key: 9560356
• MDR Text Key: 181546825
• Report Number: 2937457-2020-00041
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1