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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); Corroded (1131)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2018
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 while troubleshooting the 2008k2 hemodialysis machine for conductivity issues, it was noted that the wiring harness was corroded due to heat damage. The biomed stated that the insulation on the temperature sensors was melted due to heat damage and eventually became brittle and was crumbling off. The biomed stated that the temperature control thermistor insulations were melted and burnt. The biomed stated that it is unsure if a patient was on the machine or not at the time of the conductivity issues; however confirmed that there was no adverse events, medical intervention or injuries reported. The biomed replaced the temperature sensors. The machines has been returned to service at the user facility without recurrence of the reported issue. The complaint device is available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). 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.
 
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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 Key7572831
MDR Text Key110179470
Report Number2937457-2018-01584
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 08/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2018
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 Received08/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

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