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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.
 
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.
 
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. .
 
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Brand Name
2008T MACHINE
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
MDR Report Key11396997
MDR Text Key234202210
Report Number2937457-2021-00341
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN- 2008T MACHINE
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 02/10/2021
Initial Date FDA Received03/01/2021
Supplement Dates Manufacturer Received03/09/2021
Supplement Dates FDA Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight94
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