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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190766
Device Problems Fire (1245); Melted (1385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2020
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 fresenius field service technician (fst) was called onsite to evaluate a 2008t machine located at a hospital¿s hemodialysis (hd) unit. There was reported to be an outlet fire that melted the power plug of the machine. The reported event occurred during a patient¿s treatment on the machine. Additional information was obtained during follow up with the unit¿s biomedical technician (biomed). The biomed stated the machine powered off during the patient¿s treatment and a subsequent burning smell was noted by the registered nurse (rn) who was on duty. Hospital maintenance was called to the scene after the burning smell was noted. The rn unplugged the power cord and plugged the machine into a different outlet. Shortly afterwards, the rn noticed that the outlet the power supply was removed from was aflame. Hospital maintenance was at the scene at this point, and they blew out the flame. There was no smoke reported and the smoke detectors did not go off. Due to the situation, the patient was disconnected, and their treatment was ended. The patient was evacuated from the room. The biomed confirmed the patient did not experience any adverse effects due to the reported event, and no medical intervention was required. Maintenance removed the outlet and examined the wiring behind it to ensure there were no additional issues; none were found. The biomed stated that a fresenius fst came onsite to evaluate the machine. Prior to the start of the fst¿s machine inspection, the hospital¿s legal department decided they wanted an independent third party to perform the assessment. The fresenius fst was asked to postpone their evaluation of the machine until the third-party inspection was completed. According to the biomed, the outlet was the cause of the problem, not the machine or the power plug. The biomed stated there was no internal damage on the power plug; the damage was exclusively on the exterior of the plug. There were no other damaged components found, and though it was short-lived, the treatment was continued from a different outlet using the same power supply and plug. At the time of follow up, the third-party inspection was reportedly scheduled. The biomed stated that a copy of the results from the inspection would be shared once they are received. The biomed said the machine is up to date on its preventive maintenance (pm) checks, and confirmed the machine has no previous history of failing the electrical leakage test. The machine was out of service at the time of follow-up.
 
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Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
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 Key9784464
MDR Text Key181908639
Report Number2937457-2020-00427
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
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 03/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190766
Device Catalogue Number190766
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 Received03/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2017
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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