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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); Melted (1385); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the manufacturer is pending the return of the complaint sample for physical evaluation. A preliminary investigation of quality records was completed. 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. A definitive conclusion regarding the complaint incident is pending the return of the complaint sample and a physical evaluation.
 
Event Description
A fresenius regional equipment specialist (res) reported that a fresenius 2008t hemodialysis (hd) machine had a melted usb cable and a burnt functional board. The res was called onsite by the user facility biomedical technician (biomed) when the machine would not verify a crit-line device. The res removed and reinstalled the machine¿s functional board during troubleshooting, at which point the usb cable melted and the functional board burned. A burning smell and a spark were also observed when the usb cable and the functional board were reconnected. Upon closer inspection, the res found that a connection on the usb cable had broken off, causing the usb cable to melt and the functional board to sustain burn damage. 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 400 hours and the usb cable and functional board were original to the machine. The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the melted usb cable and the burnt functional board. The biomed replaced the functional board and soldered and taped the usb cable with electrical tape, which resolved the issue. The unit was returned to service at the user facility without issue and without reoccurrence of the event. The complaint samples are 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 Key10853137
MDR Text Key216651505
Report Number2937457-2020-02085
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 12/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received11/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2019
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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