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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190610
Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Arcing (2583)
Patient Problem No Patient Involvement (2645)
Event Date 02/13/2018
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 biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a power plug that was burned and showed signs of shorting and arcing. The power plug was cracked in multiple locations and separation of the wires was observed. The damaged power plug was noticed during heat disinfection when a burning smell and smoke was emitted from the plug. 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 plug was not the original part on the machine, however, is a fresenius part. The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components. The biomed stated that the machine is not plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, but in an emergency hospital power outlet instead. The biomed replaced the plug, which resolved the issue. The biomed reported that the machine has been returned to service without reoccurrence of the reported event. The power plug was stated to be available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Plant investigation: although it was stated that the parts were available to be returned to the manufacturer for physical evaluation, to date, no parts have been returned. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). The reported burned and melted power plug was replaced and the machine returned to service. 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. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key7307451
MDR Text Key101478096
Report Number2937457-2018-00647
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190610
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received03/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

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