MAUDE Adverse Event Report: CONCORD MANUFACTURING K2; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

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

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res).The unit was pulled from service for evaluation by the biomedical engineer (biomed) following the event.The biomed installed an air separator on the machine and completed the cbe upgrades.After the repair, machine functional checks were performed and all tests found the unit to be functioning within specification.The unit was reportedly placed into service at the user facility without any further issue.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 associated with 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 reported event of saline bag backfilled during recirculation was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A biomedical engineer (biomed) at the user facility reported that a 2008k2 hemodialysis (hd) machine had saline bag visually back filling with dialysate fluid while the unit was being set-up (recirculation) for use.There were no machine alarms.A patient was not connected to the machine at the time of the incident.Reportedly, quick disconnects are not used on the drain line.The biomed confirmed that the unit has not received the cbe hardware and software upgrades.Following the event, the unit was pulled from service for evaluation.The biomed installed an air separator into the machine that was taken from a spare machine and verified the machine was updated with the cbe software and functioned properly.Additionally, the biomed will order a new air separator as a replacement for the spare machine.The unit was returned to service at the user facility without a recurrence of the event as reported.No parts are available to be returned to the manufacturer for evaluation.

• Brand Name: K2
• 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: 6795985
• MDR Text Key: 82790106
• Report Number: 2937457-2017-00733
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/15/2017

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 Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0629-2014
• Patient Sequence Number: 1