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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 Inadequate Ultra Filtration (1656)
Patient Problem Loss of consciousness (2418)
Event Date 07/14/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: there is a possible causal relationship between the patient becoming unresponsive and their hemodialysis (hd) treatment on the fresenius 2008t machine. Per the clinic nurse, too much fluid was removed from the patient during the first hour of treatment. No treatment records have been provided and the volumes were not reported. A machine evaluation has not been completed at this time. Based on available information it cannot be confirmed if the machine removed more uf fluid then programmed causing the unresponsiveness in the patient.
 
Event Description
While following up on a reported issue with the trend screen of a fresenius 2008t machine showing incorrect information, a nurse reported a patient that became unresponsive one hour into treatment due to excessive ultrafiltration (uf) fluid removal. Once the patient was observed as unresponsive, the uf function was turned off for the remainder of the treatment. The patient was given 400ml of standard saline via the machine. The patient reportedly stayed on the machine and completed treatment without further issues.
 
Manufacturer Narrative
Plant investigation: 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 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
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 Key7777840
MDR Text Key116928248
Report Number2937457-2018-02330
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
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 Received08/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190713
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 Received08/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2016
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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