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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Viral Infection (2248); Respiratory Failure (2484)
Event Date 09/27/2021
Event Type  Death  
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 the patients death and hd therapy utilizing the 2008t hd machine. The cause of the patients death can be attributed to respiratory failure due to a covid-19 infection as reported by a medical professional. The end-stage renal disease (esrd) population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population, particularly in the environment of a covid-19 infection. Therefore, the 2008t hd machine can be excluded as a cause or contributor to this 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 patients adverse events.
 
Event Description
A biomedical technician (biomed) from a hospital hemodialysis (hd) unit reported to fresenius technical support that a patient expired while undergoing an hd treatment. The biomed did not have any additional information (including a machine serial number) on the event. There was no specific allegation the event was due to a deficiency or malfunction of any fresenius product(s) or device(s). Additional information was obtained through follow up with a hospital hd registered nurse (hdrn) who was aware of the event. The hdrn confirmed the reported patient death. The patient expired during an hd treatment on a hospital provided 2008t hd machine while admitted for a covid-19 infection (admission date unknown). During the hospitalization, it was stated the patient went into severe respiratory failure due to the covid-19 infection and was placed on mechanical ventilation. The patients health declined over the hospital course and their death was determined to be imminent by hospital staff. The hospital staff responded to a cardiac arrest alert and the patient was provided lifesaving measures. Despite attempts to restore cardiac function, the patient expired due to respiratory failure caused by the covid-19 infection. The 2008t hd machine the patient was connected to at the time of their death underwent laboratory culture testing and functional testing. It was affirmed the 2008t hd machine passed all culture testing and functional checks conducted by a hospital biomedical technician. Additionally, it was confirmed the patients death due to severe respiratory failure, caused by a covid-19 infection, and the associated hospitalization were unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).
 
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Brand Name2008T MACHINE
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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key12643508
MDR Text Key276825026
Report Number2937457-2021-02073
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN- 2008T MACHINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/15/2021 Patient Sequence Number: 1
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