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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
Device Problems Display Difficult to Read (1181); Device Issue (2379); Device Operates Differently Than Expected (2913); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
The alleged event is not confirmed. The device was not returned to the manufacturing plant for investigation. Device was scheduled for repair by the biomed technician at the clinic. An investigation of the product history records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the product history review confirmed the labeling, material, and process controls were within specification.
 
Event Description
Dialysis clinic reported a uf pump alarm in dialysis mode. Also customer states the uf pump kept turning itself off during treatment. It was reported that the treatment was completed. Uf removal goal was 3. 4ml however removal was. 18ml. The display on the dialyzer machine changed to the select program multiple times but the nurse selected dialysis and the display changed to treatment running. It was suggested by technical support that the function board may be faulty. Follow up with the clinic indicates that the patient did not experience any complications and treatment was completed on the machine. During checkup on the machine, it was determined that the uf pump was not functioning and the nurse had to hit ¿dialysis screen¿ to get the pump to function. The machine was taken off the floor for repair. At the time of the follow up, the biomed technician was still waiting for the part to arrive to repair the dialysis machine.
 
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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 Key7552982
MDR Text Key109550885
Report Number2937457-2018-01492
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008T
Device Catalogue Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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