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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 07/02/2019
Event Type  Death  
Manufacturer Narrative
Clinical review: a clinical investigation was performed. There is a temporal relationship between hd therapy on the 2008t with cdx machine and the patient event of coding with subsequent expiration. There is no information surrounding the treatment or the patient. There is no documentation to show a causal relationship between the adverse event and the machine. Additionally, there is no allegation of a machine malfunction or deficiency reported for this event. Hemodialysis patients and end stage renal disease (esrd) patients in general are at high risk of sudden cardiac death due to cardiovascular disease. Although this patient¿s comorbidities are unknown, the mortality rates are 30 times higher in esrd patients than the general population. Based on the available information there is no indication that the 2008t with cdx machine caused the patient coding and subsequent death plant investigation: no parts were returned to the manufacturer for physical evaluation. A fresenius field service technician (fst) performed an on-site evaluation of the subject hd machine. The fst completed functional checks with no errors, deviations, alarms, or problems found with machine. Machine tested negative for bleach and peroxide with test strips provided by clinic. A visual inspection of hydraulics was performed, and no leaks or problems were detected. 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 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.
 
Event Description
A user facility biomedical technician (biomed) reported that a hemodialysis patient coded. An evaluation of the machine was requested.
 
Event Description
A user facility biomedical technician (biomed) reported that a hemodialysis patient coded. An evaluation of the machine was requested due to the patient coding during treatment on the 2008t with cdx machine and subsequently expiring. There was no allegation of a device malfunction or deficiency reported at the time of the event. A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine. The res completed functional checks with no errors, deviations, alarms or problems found with the machine. The machine tested negative for bleach and peroxide with test strips provided by the clinic. The visual inspection of hydraulics with no leaks or problems detected. Multiple attempts were made to obtain additional information regarding the reported event, however, to date no new information has been provided.
 
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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
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key8797611
MDR Text Key151269940
Report Number2937457-2019-02172
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 user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number190713
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received07/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/17/2019 Patient Sequence Number: 1
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