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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008T HEMODIALYSIS SYS., WITH CDX
Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 05/09/2017
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
The biomedical technician at a user facility reported that a saline bag backfill occurred on a 2008t hemodialysis (hd) machine during pre-treatment setup. No patient was connected to the system at the time of the incident. There were no reported drain line obstructions. A fresenius regional equipment specialist (res) performed an on-site examination of the unit and was not able to duplicate the issue. Functional testing performed by the res confirmed the machine was operating properly. The unit has been returned to service at the user facility without issue. No parts were available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
No parts were returned to the manufacturer for physical evaluation. The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res). The issue was not able to be duplicated. Functional testing performed by the res confirmed that the system was operating properly. The unit has been returned to service at the user facility without a recurrence of the event as reported. 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 confirm the failure mode. The res was not able to duplicate the reported event of saline bag backfill. Therefore, the complaint has been deemed not confirmed.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
Type of DeviceDIALYZER, 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 Key6619859
MDR Text Key76964710
Report Number2937457-2017-00437
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
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,Followup
Report Date 06/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Biomedical Engineer
Device Model Number2008T HEMODIALYSIS SYS., WITH CDX
Device Catalogue Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received06/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0629-2014

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