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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
Catalog Number 190766
Device Problems Thermal Decomposition of Device (1071); Melted (1385); Arcing (2583)
Patient Problem No Patient Involvement (2645)
Event Date 05/24/2018
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 biomed technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a power cord that was arcing. The biomed stated that the power cord was burned and melted as well. The power cord was discovered during machine repair. 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 biomed reported there was no damage on any other component associated with the power cord and that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The machine has 640 hours. A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine. The power cord was replaced by the res to resolve the machine issue. Following part replacement, the res performed functional checks and confirmed the machine was operating properly. The biomed confirmed that the machine is back in service without issue and without reoccurrence of the reported event. The power cord was discarded and is not available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Device evaluation: no parts were returned to the manufacturer for physical evaluation. The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res) due to an arcing power cord. A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine. The power cord was replaced by the res to resolve the machine issue. After the repairs, machine functional checks were performed, and all tests found the unit to be functioning within specification. A records review was performed on the reported device serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances, or any associated rework during the manufacturing process which could be related to the reported event. Additionally, a review of the device history record (dhr) confirmed the results of the in-progress and final quality control (qc) testing met all the requirements. The investigation into the cause of the complaint was able to confirm the reported event.
 
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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
4040 nelson avenue
concord CA 94520
MDR Report Key7578860
MDR Text Key110467869
Report Number2937457-2018-01630
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190766
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received08/23/2018
Is This a Reprocessed and Reused Single-Use Device? No

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