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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problem Temperature Problem (3022)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
While servicing a fresenius 2008t hemodialysis (hd) machine at a user facility on (b)(6) 2018, a regional equipment specialist (res) technician reported a machine showing high temperatures in on line clearance test mode during treatment. The res technician reported that the issue could not be duplicated when he serviced the machine, and confirmed the machine passed all functional tests and returned to service. The res technician reported that at the time the high temperature issue occurred, the patient on the machine became hypertensive and was taken off the machine.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. An on-site evaluation was performed by a fresenius regional equipment specialist (res), who reported that the issue could not be duplicated, and confirmed that the machine passed all functional tests and 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.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key7637101
MDR Text Key112296987
Report Number2937457-2018-01786
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190713
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/23/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/26/2018 Patient Sequence Number: 1
Treatment
FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
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