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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 06/26/2019
Event Type  Injury  
Manufacturer Narrative
Clinical review; a temporal relationship exists between hd therapy utilizing the 2008t machine, and the serious adverse event of cardiac arrest. The bmt reported the 2008t machine passed all functional compliance testing following the code and was returned to service. Additionally, the bmt stated there was no allegation against the 2008t machine, and advised the machine was sequestered per the outpatient dialysis clinic¿s procedure following a code. Therefore, based on the totality of the information available, the 2008t machine can be disassociated from the event as there is no allegation or objective evidence indicating a product deficiency or malfunction was associated with the event. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported that a patient on hemodialysis (hd) for renal replacement therapy (rrt) coded during hd therapy. Follow-up with the user facility¿s biomedical technician (bmt) confirmed the event(s) occurrence, and the sequestering of the machine following the cardiac arrest. The bmt reported the 2008t hemodialysis machine was inspected (specifics not provided) and cultures were obtained (specifics and results not provided). Reportedly, the 2008t machine passed all functional compliance testing and was returned to service. The bmt confirmed there was no allegation against the 2008t machine, and advised the machine was sequestered per the outpatient dialysis clinic¿s procedure following a code. Additional information regarding the patient and event has been requested; however to date has not been provided.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
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
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key8827526
MDR Text Key152227457
Report Number2937457-2019-02308
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received07/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2012
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: 07/25/2019 Patient Sequence Number: 1
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