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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 190766
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Syncope/Fainting (4411)
Event Date 11/07/2021
Event Type  Injury  
Event Description
A fresenius fst (field service technician) was called on-site by a user facility to repair a 2008t machine which had an adverse event. Upon follow up, the patient¿s hd registered nurse reported this patient lost consciousness during an hd treatment and the treatment was discontinued. The patient was transferred to the hospital and was admitted for a syncopal episode. Following the admission, the patient went into cardiac arrest. The patient had return of systemic circulation after hospital staff revived the patient. The patient recovered from this event and was discharged to home within 24 hours of admission. The 2008t dialysis machine was sequestered after the event. The issue was called into fresenius technical services in order to have a fresenius fst onsite to perform a machine evaluation per hospital policy. After inspection, it was found the 2008t dialysis machine performed as intended as the machine passed all functional and diagnostic tests. There was no allegation of a product deficiency or malfunction concerning the 2008t dialysis machine or any fresenius device(s) or product(s). Additionally, it was reported that there was no relationship between the patient¿s hospitalization and the use of any fresenius device(s) or product(s). The patient continues hd therapy on an in-center basis following this event.
 
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between the patient¿s loss of consciousness and hd therapy utilizing the 2008t hd machine. The root cause of the patient¿s loss of consciousness was not reported and, therefore, cannot be determined; however, it was confirmed this patient¿s adverse event was unrelated to hd therapy or the use of any fresenius product(s) or device(s). This is further evidenced by the patient¿s cardiac arrest following transport to the hospital whereas the patient¿s loss of consciousness was more than likely a sign of the impending arrest and/or significant cardiovascular disease. Additionally, syncope is a common occurrence during dialysis treatments, typically due to hypotension caused by underlying cardiac disease. Therefore, the 2008t hd machine can be excluded as a potential source or contributor to this adverse event. Based on the required 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. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
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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
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 Key13480991
MDR Text Key285253129
Report Number2937457-2022-00208
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 Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190766
Device Catalogue Number190766
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2016
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: 02/08/2022 Patient Sequence Number: 1
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