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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 Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 08/27/2020
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 hemodialysis (hd) user facility contacted technical support (ts) to request onsite service for a fresenius 2008t hd machine. The machine reportedly ¿caught fire¿. Additional information was obtained via follow-up with a biomedical technician (biomed) from the facility. The biomed stated the event occurred after hours while the machine was in heat disinfect; there was no patient involvement. The biomed was not present during the event; however, the biomed spoke with a technician who witnessed it firsthand. The technician told the biomed that the machine turned off with a ¿power fail¿ alarm, while in heat disinfect. The technician noted a burning smell, and then heard (and saw) a spark come from the outlet that the machine was plugged into. The technician stated the machines power plug then caught on fire. The technician grabbed a fire extinguisher, immediately put out the fire (described as a small flame), and quickly removed the power cord from the outlet. There was no smoke reported, and the smoke detectors did not go off. No treatments were impacted; there were no patients present at the facility. The event left behind burn marks on the power plug and power cord. The power plug looked charred and exhibited signs of melting. The machine was pulled from the floor for evaluation and a fresenius field service technician (fst) was called onsite to inspect it. The fst replaced the power cord and took the damaged one with them when they departed. After the repair was completed, the machine passed functional testing and was deemed ready to be returned to service. During follow-up, the biomed confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. It was also confirmed that the machine had no previous history of failing the electrical leakage test. According to the fst¿s service report, the machine had 3,898 hours on it at the time of the repair. It was reported that an electrician came onsite to replace three outlets, which included the outlet this machine was plugged into. The other two outlets were stationed on the same wall. Pictures of the damaged power cord and plug were provided for review. It was unknown if the parts were available to be returned for 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 Key10558007
MDR Text Key207679469
Report Number2937457-2020-01697
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,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2020
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 Received09/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2019
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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