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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 02/12/2019
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: a temporal relationship exists between hd therapy with the 2008t hemodialysis machine and the patient¿s cardiac arrest during hd therapy on (b)(6) 2019. However, based on the information available, the 2008t hemodialysis machine can be disassociated from this event, as there is no evidence a machine deficiency or malfunction was associated with this event. Per the nurse present at the event, the event was unrelated to the functionality of the 2008t hemodialysis machine. The patient¿s reported instability was the primary causal factor in this event. Additionally, the 2008t hemodialysis machine passed all functional compliance testing following the event.
 
Event Description
On (b)(6) 2019 a biomedical technician called fresenius technical support to request functional compliance testing on a 2008t hemodialysis (hd) machine. The bio-medical technician reported this (b)(6)-year-old male patient with end stage renal disease (esrd) on hd for renal replacement therapy (rrt) cardiac arrested during hd therapy on (b)(6) 2019. Follow-up revealed the patient was vented, and reportedly being dialyzed without the removal of fluid due to instability. 1:45 minutes into a 2. 0-hour hd treatment, the nurse noted the patient¿s heart rate was not registering on the ventilator and called a code. The hd therapy was discontinued; however, no further details are available. The patient survived the cardiac arrest; however, remains in critical condition. During follow-up the nurse stated the patient¿s condition is not improving, and the patient can no longer tolerate hd therapy. Additional details surrounding the patient¿s hospitalization were requested; however, the request was declined. The nurse reported the cardiac arrest was unrelated to the functionality of the 2008t hd machine. The nurse stated she was just following protocol when she requested the functional compliance testing and was not expecting any findings. A fresenius regional equipment specialist (res) inspected the machine on (b)(6) 2019 confirmed the machine was performing within manufacturer specifications during the event. All functional compliance testing was passed.
 
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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 Key8369559
MDR Text Key137119436
Report Number2937457-2019-00604
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190713
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received03/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2018
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: 02/26/2019 Patient Sequence Number: 1
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