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

Model Number 190858

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2020

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 to technical support that the cdx side was not working on a fresenius 2008t hemodialysis (hd) machine.The biomed had recently replaced the function board, the eeprom, and the actuator test board.One of the pins on the eeprom was reportedly damaged from being melted or shorted.During follow up, it was reported that the machine was initially pulled from service due to conductivity issues.During their inspection of the machine was when the biomed discovered that one of the pins on the eeprom had melted.The biomed suspected that it shorted out.There was no burning smell noted, and there were no reports of smoke, sparks, flames, or charring.The biomed also reported replacing the sensor board.These repairs resolved the conductivity issue, and the machine subsequently passed all testing.However, the biomed had not returned the machine to service as they were still having trouble connecting the machine to the hospital¿s electronic medical record (emr) system.The biomed stated that the connection issue was not machine related; they were waiting on assistance from the hospital¿s information technology (it) group.Aside from the melted pin, no further damage was identified on any other machine components.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.The biomed stated there were 13,469 hours on the machine.The replaced parts were not available to be returned for evaluation as they were reportedly discarded.Photos of the melted pin on the eeprom were not available.The biomed confirmed there was no patient involvement associated with the reported event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 SYSTEM WITHOUT 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: 10423961
• MDR Text Key: 203456250
• Report Number: 2937457-2020-01492
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (y/n): N
• PMA/PMN Number: K113427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

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: 190858
• Device Catalogue Number: 190858
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 08/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1