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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
Catalog Number 190713
Device Problems Thermal Decomposition of Device (1071); Arcing (2583); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 09/23/2019
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported that a fresenius 2008t machine had an arc after the metal in the power supply was crossed. The biomed stated that a spark was observed, and the power plugs were burned. There was no patient involvement during the event. There was no flame or smoke observed. The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components. The machine has approximately 28,000 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. There was no voltage, however there was voltage from the outlet. The biomed checked the 120vac and tried another outlet. The power supply, power logic board, the motherboard and the front panel keypad were replaced. After installing a replacement actuator board and mother board, the machine displayed the following message: "active pressure regulator not calibrated. " the biomed stated that the issue was resolved, and the machine has been returned to service without issue. The power plugs were reported to be available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Plant investigation: although it was stated that the complaint device was available to be returned, to date no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). 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 related to 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.
 
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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
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key9157139
MDR Text Key161233294
Report Number2937457-2019-03119
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
Type of Report Initial,Followup,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190713
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 Received11/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2011
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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