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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING K2 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING K2 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008K2
Device Problem Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 09/27/2017
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed. However, an investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformance during the manufacturing process. All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure. A device is not released if it does not meet requirements or is nonconforming. In addition, the device record review confirmed the labeling, material, and process controls were within specification.
 
Event Description
A biomedical engineer (biomed tech) reported during heat disinfect mode the machine had a high temperature and displayed a low conductivity message. There was no patient involvement at the time of the event. There were no audible alarms because the dialysate lines were on the shunt. The temperature did not drop when the biomed tech turned off the heater switch on the back of the power supply. He found the insulation crumbling off the wires of all three temp sensors. Additional follow-up information received on 12/06/2017 revealed the shielding on wires was sticky to touch, melting off wire, and chunks of shielding was missing. Per biomed tech the issue was resolved by replacing all three thermistors sensors and calibrating the temperature, and the machine was returned to service without a recurrence of the reported issue. The. All three thermistors in machine had damaged wires and the parts were disposed of.
 
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A biomedical engineer (biomed tech) reported during heat disinfect mode the machine had a high temperature and displayed a low conductivity message. There was no patient involvement at the time of the event. There were no audible alarms because the dialysate lines were on the shunt. The temperature did not drop when the biomed tech turned off the heater switch on the back of the power supply. He found the insulation crumbling off the wires of all three temp sensors. Additional follow-up information received on 12/06/2017 revealed the shielding on wires was sticky to touch, melting off wire, and chunks of shielding was missing. Per biomed tech the issue was resolved by replacing all three thermistors sensors and calibrating the temperature, and the machine was returned to service without a recurrence of the reported issue. The. All three thermistors in machine had damaged wires and the parts were disposed of.
 
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Brand NameK2
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7095231
MDR Text Key252424578
Report Number2937457-2017-01304
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Biomedical Engineer
Device Model Number2008K2
Device Catalogue Number190610
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 Received12/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2010
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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