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 05/25/2022

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 reported that a 2008k2 hemodialysis (hd) machine experienced a saline bag backfill during the setup (prime) process in dialysis mode.The field service technician (fst) stated there is an air separator adapter board installed on this machine.The fst verified there was no patient involvement associated with the reported issues.The machine was in the setup process in dialysis mode when this occurred.User error was not a contributing factor.The machine had 31,973 hours on it at the time of the event.The machine did not give any filling programs.The fst confirmed the machine had upgrades for the changes being effected (cbe) completed, and verified that the drain line length and height were within specification.To resolve the reported issue, the fst replaced the air separator assembly piggy back board on the distribution board position number six and the tmp was calibrated.The machine was subsequently returned to service.The used parts were not available to be returned for evaluation.

Manufacturer Narrative

Initial submission date received 05/25/2022.

Event Description

A user facility reported that a 2008k2 hemodialysis (hd) machine experienced a saline bag backfill during the setup (prime) process in dialysis mode.The field service technician (fst) stated there is an air separator adapter board installed on this machine.The fst verified there was no patient involvement associated with the reported issues.The machine was in the setup process in dialysis mode when this occurred.User error was not a contributing factor.The machine had 31,973 hours on it at the time of the event.The machine did not give any filling programs.The fst confirmed the machine had upgrades for the changes being effected (cbe) completed, and verified that the drain line length and height were within specification.To resolve the reported issue, the fst replaced the air separator assembly piggy back board on the distribution board position number six and the tmp was calibrated.The machine was subsequently returned to service.The used parts were not available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Investigation determines that there was causal relationship between the objective evidence and the alleged event; the alleged event is confirmed.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 be confirmed.

Event Description

A user facility reported that a 2008k2 hemodialysis (hd) machine experienced a saline bag backfill during the setup (prime) process in dialysis mode.The field service technician (fst) stated there is an air separator adapter board installed on this machine.The fst verified there was no patient involvement associated with the reported issues.The machine was in the setup process in dialysis mode when this occurred.User error was not a contributing factor.The machine had 31,973 hours on it at the time of the event.The machine did not give any filling programs.The fst confirmed the machine had upgrades for the changes being effected (cbe) completed, and verified that the drain line length and height were within specification.To resolve the reported issue, the fst replaced the air separator assembly piggy back board on the distribution board position number six and the tmp was calibrated.The machine was subsequently returned to service.The used parts were not available to be returned for evaluation.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14551175
• MDR Text Key: 295342764
• Report Number: 0002937457-2022-00858
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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