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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- 2008T MACHINE
Device Problem Inadequate Ultra Filtration (1656)
Patient Problems Edema (1820); Headache (1880); Low Blood Pressure/ Hypotension (1914); Swelling/ Edema (4577)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported that a hemodialysis (hd) patient is constantly having issues (exact dates, occurrences not provided) with how much fluid the clinic staff does or does not remove during treatment. The patient does not like too much fluid removed as they do not feel well after with headaches. The staff has a hard time controlling the patient's blood pressure (bp) during treatment. The bp drops low so then they need to administer fluids to counter the bp issue. The hd nurse said it is a constant balancing act to keep the correct amount of fluid off without giving the patient symptoms and without leaving too much fluid on. The hd nurse stated the patient is non-compliant with diet and medication. The patient always comes to treatment with signs of edema in their legs and abdomen and with swollen eyelids. The patient does not have have any fluid in their lungs. The patient admits to drinking too much over the weekend and between treatments. The nurse practitioner prescribed the patient midodrine for the low bp which the patient is refusing to take until they see their primary care physician.
 
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Brand Name2008T MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
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 Key11396997
MDR Text Key234202210
Report Number2937457-2021-00341
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN- 2008T MACHINE
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 Received03/09/2021
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

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