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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 Death (1802)
Event Date 06/11/2018
Event Type  Death  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
A biomedical technician at a user facility reported a patient who expired at the end of their (b)(6) 2018 treatment. Upon follow up with the clinic nurse, it was confirmed, the patient had no known exacerbated comorbid conditions which could have caused or contributed to the event. The nurse advised she was told the patient was not taking her prescribed blood pressure medication as ordered at the time of her death; although the specifics are unknown. While the clinic biomedical technician initially advised that the fresenius 2008t machine failed the standard functional compliance testing after the adverse event, the regional equipment specialist inspected and tested the machine and confirmed the machine was performing according to manufacture specifications. Subsequent attempts at obtaining additional information have thus far proven unsuccessful. Should additional information become available, the file will be updated accordingly.
 
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis machine, and the patient¿s adverse event of death. The etiology of the event is unknown; therefore causality cannot be determined. It was reported the patient was non-complaint with blood pressure medications; however to what extent this may have affected the event is unknown. Based on the lack of information available, and due to the fact the patient was in active treatment at the time of the event; a causal relationship cannot be ruled out. The biomedical technician initially reported the 2008t hemodialysis machine failed post-event functional compliance testing (specifics unknown), however subsequent regional equipment specialist testing did not confirm any machine failures. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   correction: date of death added.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformance, or any associated rework identified during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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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
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7692538
MDR Text Key114134377
Report Number2937457-2018-01988
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100897
UDI-Public00840861100897
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,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2018
Is this an Adverse Event Report? Yes
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 Received08/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2017
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: 07/16/2018 Patient Sequence Number: 1
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