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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); Nausea (1970)
Event Date 09/11/2018
Event Type  Death  
Manufacturer Narrative
Plant investigation: a fresenius regional equipment specialist (res) later inspected the machine, which passed all functional tests without issue. The machine 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. Clinical investigation: there is a temporal relationship between hd therapy on the 2008t machine and the patient complaint of nausea with subsequent cardiac arrest and death. There is no documentation to show a causal relationship between the adverse event and the 2008t machine. Additionally, there is no allegation of a machine malfunction or deficiency reported for this event. The machine was evaluated and returned to service with no issues found. Based on available information the cause of the nausea and subsequent cardiac arrest and death cannot be confirmed.
 
Event Description
A user facility reported a patient who "complaint" of nausea 1. 5 hours into their (b)(6) 2018 hemodialysis treatment on a fresenius 2008t machine. Upon follow up with the clinic manager, it was learned that the patient was brought to the hospital and subsequently expired on (b)(6) 2018 due to cardiac arrest. A fresenius regional equipment specialist (res) later inspected the machine, which passed all functional tests without issue, and confirmed the machine returned to service.
 
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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 Key7910370
MDR Text Key121762697
Report Number2937457-2018-02877
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 Biomedical Engineer
Type of Report Initial
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event 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 Age MO
Event Location No Information
Date Manufacturer Received09/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2018
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: 09/26/2018 Patient Sequence Number: 1
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