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

Model Number 2008K2

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

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2017

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 report is being investigated by the manufacturer via a capa. The plant investigation is in process. A supplemental mdr will be submitted upon the completion of this activity.

Event Description

A biomedical engineer at the user facility reported that a 2008k2 hemodialysis (hd) machine had high transmembrane pressure (tmp) of 500mmhg with back pressure to the saline bag while the unit was being set-up for use. A patient was not connected to the machine at the time of the incident. Reportedly, a staff member observed the solution backfill into the saline bag and the bag ¿puffed up. ¿ the biomed confirmed that the unit had received the cbe hardware and software upgrades before the end of 2016. Following the event, the unit was pulled from service for evaluation. The unit remains out of service while the biomed attempts to troubleshoot the issue. No further information has been made available.

Manufacturer Narrative

Correction - removed notification remedial action selection and notification # z-0629-2014. The cbe upgrade was performed on this unit. Therefore, this 2008k2 hemodialysis (hd) machine no longer falls within the scope of this recall. 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. However, no further details were able to be obtained regarding the status of the machine. 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 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 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; 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: 6383501
• MDR Text Key: 69274119
• Report Number: 2937457-2017-00146
• 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,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2008K2
• Device Catalogue Number: 190610
• Other Device ID Number: 00840861100859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2012
• 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 Treatment Data

Date Received: 03/07/2017 Patient Sequence Number: 1

Treatment

SALINE (UNKNOWN)