MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMO. SYS. OLC/DIASAFE PLUS,W/O HP; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K

Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

No parts have been returned to the manufacturer for physical evaluation.There have been no adverse events associated with the reported issue.The 2008k hemodialysis (hd) machine was evaluated at the facility by a fresenius regional equipment specialist (res).Machine functional checks were performed.No system issues were identified during the on-site evaluation.The res could not duplicate the problem and confirmed that the unit was operating properly.No malfunction of the 2008k hd machine observed or identified during the on-site evaluation.The unit remains out of service pending approval from the facility management.No further information has been made available.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 found during the manufacturing process which could be associated with the reported event.In addition, the review of the in-progress and final quality control testing of the device confirmed that the results were within specification.The reported event of saline bag backfilled during recirculation was not able to be confirmed.Functional testing performed by the res confirmed that the system was operating properly.Therefore, the complaint has been deemed not confirmed.

Event Description

A biomedical engineer (biomed) at the user facility reported that a 2008k hemodialysis (hd) machine had fluid backfilling into the saline bag while the unit was being set-up (prime) for use.A patient was not connected to the machine at the time of the incident.Reportedly, a staff member observed the unit had transmembrane pressure issues during set-up and then suddenly observed the solution backfill into the saline bag.The biomed confirmed that the unit had received the (b)(6) hardware and software upgrades in (b)(6) 2016.Following the event, the unit was pulled from service for evaluation.A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine.The res confirmed that there were no leaks or hydraulic pressure issues.The res could not duplicate the problem and confirmed that the unit was operating properly.The unit remains out of service pending approval from the facility management.No further information has been made available.

• Brand Name: 2008K HEMO. SYS. OLC/DIASAFE PLUS,W/O HP
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6419099
• MDR Text Key: 70409542
• Report Number: 2937457-2017-00185
• Device Sequence Number: 1
• Product Code: KDI
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2008K
• Device Catalogue Number: 190372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2007
• 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
• Treatment: SALINE (UNKNOWN)