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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008K 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 Death (1802); Myocardial Infarction (1969)
Event Date 02/06/2018
Event Type  Death  
Manufacturer Narrative
The plant investigation is in progress. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
It was reported that a patient passed away coincident with hemodialysis dialysis therapy. The patient¿s death certificate listed the cause of death as unknown. The patient¿s death certificate listed the patient to be on continuous ambulatory peritoneal dialysis (capd) treatment, however the peritoneal dialysis registered nurse clarified that the patient was on hemodialysis prior to passing away and not capd. The patient reportedly had a heart attack in their home and was transported to the emergency room via ambulance. The patient was not actively dialyzing at the time of the event. The patient was reported to have completed their hemodialysis treatment successfully on (b)(6) 2018 without any issues noted. Additional information was requested but was not available.
 
Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained. As a serial number could not be determined, device history and manufacturing records could not be reviewed. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed. Should additional relevant information become available, a supplemental report will be submitted. 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 evidence or documentation supporting a possible causal association between hemodialysis (hd) therapy on the 2008k machine, and the patient event(s) of myocardial infarction and subsequent death. Per the registered nurse¿s statement on (b)(6) 2018 the patient had received their last hd treatment on (b)(6) 2018, and was not actively performing renal replacement therapy (rrt) at the time of the event(s). Additionally, there is no documentation or allegation that any fresenius device(s) caused or contributed to the patients¿ myocardial infarction and/or death. It is unknown if any association exists between the patients¿ comorbid conditions and event(s) of myocardial infarction and death. The esrd death notification states the cause of death is unknown.
 
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Brand Name2008K 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 Key7360623
MDR Text Key103128690
Report Number2937457-2018-00856
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received03/23/2018
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: 03/21/2018 Patient Sequence Number: 1
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