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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 Patient Involvement (2645)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
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 heater rod. 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 burnt wire on the heater rod. Therefore, the complaint event was confirmed.
 
Event Description
A fresenius field service technician (fst) reported that a fresenius 2008t hemodialysis (hd) machine had a heater rod with a burnt wire. The burnt wire was noticed during machine repair. There was no burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burnt wire. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. The machine has approximately 3,155 hours and the heater rod was original to the machine. The fst reported that there was no damage observed on any other components, or any other additional issues, associated with the burnt wire on the heater rod. The fst replaced the heater rod, which resolved the reported issue. The machine passed all testing and was returned to service. The heater rod is available to be returned to the manufacturer for physical evaluation.
 
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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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11008911
MDR Text Key221446399
Report Number2937457-2020-02251
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 company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received11/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2019
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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