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 Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2020

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 following parts were replaced: the 24v cable, the power logic board, and the power control 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.A fresenius fst successfully repaired the 2008t machine and returned it to service.

Event Description

A user facility biomedical technician (biomed) reported to technical support (ts) that a fresenius 2008t hemodialysis (hd) machine was displaying an intermittent 12v power failure message in combination with audible alarms.The biomed stated it was occurring during rinse mode; there was no patient involvement.The machine was pulled from service for evaluation.During troubleshooting, the biomed pulled out the card cage to check for loose wires on the backside and didn¿t see any.The biomed closed the card cage and noticed sparks come out from behind the machine.The biomed turned the machine off and pulled out the card cage again to take a closer look.Further inspection revealed there was a cut on one of the red wires (from the 24v cable).The biomed replaced the cable, and this seemed to have resolved the issue.However, the next day (while the machine was still out of service), the alarm reoccurred.The biomed called ts back to order a power logic board.The biomed replaced the power logic board when the part arrived, but this still did not fix the machine.At this point, the biomed requested on-site service from a fresenius field service technician (fst).An fst evaluated the machine and reported that an arterial blood pump no communication message was occurring.The fst replaced the power control board to resolve the issue.There were reported to be 1,246 hours on the machine when the fst completed the repair.After the repair was completed, the machine was returned to service and has been functioning without issue since.The biomed confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.No damage was identified on any other components.The damaged 24v cable was discarded, and thus, not available to be sent back for evaluation.No photographs of the damaged cable were available.It was unknown if the other replaced parts were available to be returned for evaluation.

• 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: 10117512
• MDR Text Key: 194298593
• Report Number: 2937457-2020-00983
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• 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
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1