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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 Arcing (2583)
Patient Problem No Patient Involvement (2645)
Event Date 12/17/2019
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 2008t machine experienced a valve 104/108 stuck closed alarm. The machine was pulled from service and a fresenius field service technician (fst) was called onsite to perform an evaluation of the machine. During the evaluation, the fst reportedly found signs of arcing on the bibag distribution board. The fst ordered a part to repair the machine and then left the facility. By the time the fst returned to the facility with the replacement part in hand, the machine had already been returned to service. Upon follow up, the biomed stated the machine was no longer experiencing any issues and was therefore returned to service. The biomed stated there were no parts replaced or calibrated. It was confirmed that the machine stays plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The biomed was unsure if the machine had a previous history failing the electrical leakage test. The machine was in service at the time of follow up and reported to be fully operational. Upon follow up with the fst, it was reported that ¿black streaks¿ were noted on the bibag distribution board. The fst stated the black streaks are indicative of arcing. The black streaks were present on the component where the ribbon cable and pins connect to the board. Photographs of the black streaks were requested, but none were taken. There was no reported smoke, sparks, flames or burning smell. The fst confirmed the machine had been returned to service prior to repairing it and verified with the biomed that there have been no further issues. The fst surmised that the circuit board got wet, leaving behind evidence of arcing in the form of black streaks. There was no patient involvement associated with the reported event.
 
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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 Key9560356
MDR Text Key181546825
Report Number2937457-2020-00041
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 01/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2020
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 Age MO
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2019
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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