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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
Model Number 190713
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Dyspnea (1816)
Event Date 11/19/2021
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 utilizing the 2008 hd machine and the patient¿s chest pain and dyspnea. The cause of the patient¿s symptoms cannot be determined; however, it was confirmed this event was not due to a deficiency or malfunction of any fresenius product(s) or device(s) by a medical professional. It is well known hd patients may experience acute complications associated with multi-comorbidity and/or the patient¿s physiological response to normal hd therapy. Therefore, the 2008 hd machine can be excluded as root cause of this patient¿s adverse event. Based on the available information, there is no specific allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s adverse event.
 
Event Description
It was reported to fresenius technical support (ts) that a hemodialysis (hd) patient experienced a cardiac arrest during hd treatment. The user facility requested onsite service from a fresenius field service technician (fst) to evaluate the 2008 hd machine that was being utilized. Upon follow up with the patient¿s hd registered nurse, it was reported this patient experienced chest pain and shortness of breath during an hd treatment. The patient developed symptoms approximately 30 minutes after the initiation of hd and the treatment was discontinued. The patient was provided oxygen and blood was returned to the patient. Emergency services were activated, and the patient was transported to the emergency department (ed) of a local hospital. It was found the patient did not experience a cardiac arrest and did not require medical intervention beyond oxygen administration. The patient was found to be negative for a cardiac event as an electrocardiogram and laboratory tests taken in the ed resulted in normal cardiac function. The patient was released to home from the ed with no hospital admission. The cause of the patient¿s symptoms was unknown; however, they were ruled out for a dialyzer reaction or any other adverse event relating to the hd treatment. Additionally, it was confirmed the patient¿s dyspnea, chest pain, and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s). The patient continues hd on an in-center basis following this event. The fst confirmed the 2008 hd machine was operating properly. No issues were found during functional testing of the machine.
 
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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
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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key12911279
MDR Text Key284003455
Report Number2937457-2021-02376
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 Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190713
Device Catalogue Number190713
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2012
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: 12/01/2021 Patient Sequence Number: 1
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