MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190610

Device Problems Mechanical Problem (1384); Reflux within Device (1522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

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 hemodialysis (hd) biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008k2 hd machine was giving a filling program message in setup and the saline bag was filling.During follow-up, the biomed confirmed being told that a saline bag backfill had occurred during priming.The biomed was unable to speak directly with the staff member who saw this happen.Furthermore, the biomed reported this individual was no longer employed at the facility which hindered their ability to properly troubleshoot the issue.The biomed could not confirm what the staff member did or did not see.They could not confirm if the individual visually observed the saline bag refilling with dialysate.The biomed confirmed the drain line length and height were within specification and stated there were no quick disconnects used on the drain line.The biomed did not know if the saline bag backfill was due to use error.Upon completion of their machine evaluation, the biomed concluded that ¿the air separator was not doing its job¿.They replaced the air separator to resolve the reported issue.The biomed was aware that a cbe software upgrade had to be performed on the machine, and they confirmed receiving the upgrade kit which was ordered during a separate call to ts.At the time of follow-up, the biomed acknowledged that the upgrade still needed to be performed.The machine was tested and primed with saline prior to being returned to service and the issue did not reoccur.No further issues have been reported on the machine, and no parts were available to be returned for manufacturer evaluation.There was no patient involvement associated with the reported issue.

Event Description

A hemodialysis (hd) biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008k2 hd machine was giving a filling program message in setup and the saline bag was filling.During follow-up, the biomed confirmed being told that a saline bag backfill had occurred during priming.The biomed was unable to speak directly with the staff member who saw this happen.Furthermore, the biomed reported this individual was no longer employed at the facility which hindered their ability to properly troubleshoot the issue.The biomed could not confirm what the staff member did or did not see.They could not confirm if the individual visually observed the saline bag refilling with dialysate.The biomed confirmed the drain line length and height were within specification and stated there were no quick disconnects used on the drain line.The biomed did not know if the saline bag backfill was due to use error.Upon completion of their machine evaluation, the biomed concluded that ¿the air separator was not doing its job¿.They replaced the air separator to resolve the reported issue.The biomed was aware that a cbe software upgrade had to be performed on the machine, and they confirmed receiving the upgrade kit which was ordered during a separate call to ts.At the time of follow-up, the biomed acknowledged that the upgrade still needed to be performed.The machine was tested and primed with saline prior to being returned to service and the issue did not reoccur.No further issues have been reported on the machine, and no parts were available to be returned for manufacturer evaluation.There was no patient involvement associated with the reported issue.

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: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 11632055
• MDR Text Key: 244664476
• Report Number: 2937457-2021-00630
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1