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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008T
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Lethargy (2560)
Event Date 04/05/2018
Event Type  Injury  
Manufacturer Narrative
A temporal relationship exists between hd therapy on the 2008t hemodialysis machine and the adverse event(s) of hypotension and lethargy. However, there is no documentation or evidence indicating a causal relationship between the 2008t hemodialysis machine and the adverse event(s), as the machine performed within specification during follow-up functional compliance and ultrafiltration testing. There is no allegation that any fresenius device(s) malfunctioned or failed to perform as expected. Intradialytic hypotension is well-established as one of the leading complications of hd therapy. The device was repaired in the field and returned to service. An investigation of the product history records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the product history review confirmed the labeling, material, and process controls were within specification.
 
Event Description
Contact from a hemodialysis clinic reported an adverse event with a patient while receiving hemodialysis treatment. It was reported that the patient¿s blood pressure dropped, was lethargic and subsequently moved to the icu and was given intravenous fluids. The patient condition reportedly improved. The clinic contact requested to have the dialysis machine evaluated. Additional information was solicited.
 
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Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
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 Key7459462
MDR Text Key106581936
Report Number2937457-2018-01151
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2008T
Device Catalogue Number190766
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 Received04/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2016
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: 04/25/2018 Patient Sequence Number: 1
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