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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191126
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2022
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A field service technician (fst) reported to fresenius that a 2008t machine had damage to power control board due to a power surge. Preventative maintenance was performed on the machine and it was found that the resistor of the power control board had been burnt and scorched. The power supply assembly was replaced and the machine and to power back on without issue. The machine was tested and returned to service without further issue. Upon follow-up the fst confirmed there was no smoke or burning smell that was reported by the facility. The fst stated there was no patient involvement, no harm or adverse event reported. The machine was successfully repaired and placed back in service without further issue.
 
Event Description
A field service technician (fst) reported to fresenius that a 2008t machine had damage to power control board due to a power surge. Preventative maintenance was performed on the machine and it was found that the resistor of the power control board had been burnt and scorched. The power supply assembly was replaced and the machine and to power back on without issue. The machine was tested and returned to service without further issue. Upon follow-up the fst confirmed there was no smoke or burning smell that was reported by the facility. The fst stated there was no patient involvement, no harm or adverse event reported. The machine was successfully repaired and placed back in service without further issue.
 
Manufacturer Narrative
Correction: plant investigation: no parts were returned to the manufacturer for physical evaluation. However, an on-site evaluation was performed by a fresenius field service technician (fst). To resolve the reported issue, the fst replaced the power supply assembly to resolve the 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 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 able to confirm the reported failure mode. During the machine inspection, the fresenius fst identified the resistor of the power control board had been burnt and scorched. Therefore, the complaint event was confirmed.
 
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Brand Name2008T HD SYS. CDX W/BIBAG BLUE STAR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14317325
MDR Text Key291191153
Report Number0002937457-2022-00747
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received06/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2022
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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