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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K HEMODIALYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Infarction, Cerebral (1771); Death (1802)
Event Date 08/01/2017
Event Type  Death  
Manufacturer Narrative
Clinical investigation: a clinical investigation was performed to identify a causal relationship between the peritoneal dialysis (pd) treatment and the adverse event. Based on the provided information there is no documentation that indicates a temporal association exists between the 2008k hemodialysis (hd) machine and the patient¿s stroke, cardiac arrest event resulting in patient death. Additionally, there is no allegation or documentation to support a causal relationship between the 2008k machine and the patient¿s stroke, cardiac arrest and death. End stage renal disease (esrd) patients are at high risk for mortality with cardiac disease is the largest single cause of death for both hemodialysis and peritoneal dialysis patients. The cause of the patient¿s cardiac arrest event is unknown at this time. Should additional information become available, this clinical investigation will be reassessed accordingly. Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the serial number of the hemodialysis (hd) machine in question was not known. However, all device history records (dhr) are reviewed and released according to the "dhr review checklist & release procedure" p/n 500658; a device is not released if it does not meet requirements or is nonconforming.
 
Event Description
A hemodialysis (hd) patient of approximately 3 months was reported to be have experienced stroke on unknown date while hospitalized. During the course of hospitalization the patient subsequently had a cardiac arrest and expired. The hd machine and products used at the time of the patient¿s final hd treatment are unknown. There was no indication of any malfunction with any of the product(s) or device(s) in use during the hd treatment. However, no further information have been made available regarding the manufacturer of the products used during the patient's hd treatment.
 
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Brand Name2008K HEMODIALYSIS MACHINE
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 Key7026902
MDR Text Key91872203
Report Number2937457-2017-01178
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 11/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Device Operator
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 Received10/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/13/2017 Patient Sequence Number: 1
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