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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
Model Number 2008T
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 10/29/2018
Event Type  Death  
Manufacturer Narrative
Plant investigation: a fresenius regional equipment specialist (res) evaluated the machine, and confirmed the machine passed all functional tests without issue. A review of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements. Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event. The cycler performed as designed and an associated cause could not be determined.
 
Event Description
A user facility reported a patient who coded during their (b)(6) 2018 treatment on a fresenius 2008t hemodialysis machine and later expired. A fresenius res (regional equipment specialist) technician was called onsite to inspect the machine. The machine passed all functional tests without issue. Due diligence attempts were exhausted, but additional information was not received.
 
Manufacturer Narrative
Clinical investigation: 10/29/2018, a hemodialysis (hd) user facility reported that this male patient on thrice weekly hd for the past 10 months went into cardiac arrest during treatment. The patient subsequently expired. The cause of death is listed as acute myocardial infarction (mi). No information was provided for resuscitation efforts or if the patient was transported to the hospital. Attempts to obtain additional information were made, however, no response was received. A fresenius regional equipment specialist (res) evaluated the machine. The machine passed all functional testing and there was no machine malfunction. There is a temporal relationship between the patient hd treatment on the 2008 t machine and the event of cardiac arrest and subsequent death as the event occurred during hd treatment. However, there is no documentation of a causal relationship between the machine and the event. Based on the available information the cause of the myocardial infarction with subsequent death cannot be confirmed.
 
Manufacturer Narrative
Required intervention changed to yes. Updated event description added. Updated clinical investigation: on (b)(6) 2018, a hemodialysis (hd) user facility reported that this male patient on thrice weekly hd for the past 10 months went into cardiac arrest post treatment. The patient subsequently expired. The cause of death is listed as acute myocardial infarction (mi). No information was provided for resuscitation efforts or if the patient was transported to the hospital. Attempts to obtain additional information were made, however, no response was received. A fresenius regional equipment specialist (res) evaluated the machine. The machine passed all functional testing and there was no machine malfunction. There is a temporal relationship between the patient completing hd treatment on the 2008t machine and the event of cardiac arrest and subsequent death as the event occurred shortly after ending hd treatment. However, there is no documentation of a causal relationship between the machine and the event. The machine passed all functional testing during evaluation. It is unknown if the patient has pre-existing cardiac issues that could have caused or contributed to the event. Based on the available information the cause of the myocardial infarction with subsequent death cannot be confirmed.
 
Event Description
A user facility reported a hemodialysis patient coded immediately after their (b)(6) 2018 treatment on a fresenius 2008t hemodialysis machine and later expired. A fresenius res (regional equipment specialist) technician was called onsite to inspect the machine. The machine passed all functional tests without issue. Due diligence attempts were exhausted, but additional information was not received.
 
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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 Key8077476
MDR Text Key127355706
Report Number2937457-2018-03405
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 company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number2008T
Device Catalogue Number190713
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received12/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2017
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: 11/16/2018 Patient Sequence Number: 1
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