• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM WITHOUT CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM WITHOUT CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190858
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 11/17/2018
Event Type  Death  
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system without cdx and the event(s) of hypotension, cardiac arrest and subsequent death. The hdrn stated the cause of death was cardiac arrest, and reported the patient had a past medical history including cardiovascular disease. Cardiovascular morbidity and mortality are known to be significantly higher in esrd patients, when compared to the general population. Based on the information available the 2008t hemodialysis system without cdx can be disassociated from the event, as there is no evidence or indication a fresenius product(s) or device(s) caused or contributed to a serious adverse event. Additionally, there is no allegation or evidence of a machine malfunction or of the machine failing to perform as expected in relation to the event. It was reported the 2008t hemodialysis system without cdx passed all function compliance testing following the event. Should additional information become available, the need for a clinical investigation will be re-evaluated accordingly.
 
Event Description
On (b)(6) 2018, a user facility hemodialysis registered nurse [hd(rn)] called fresenius technical support regarding this (b)(6) male patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) experiencing hypotension, cardiac arrest and subsequent death during hd therapy on (b)(6) 2018. During follow-up on (b)(6) 2018, the hdrn stated the patient was hypotensive (timeline and values not provided) and subsequently ¿coded¿ (details not provided) approximately 1. 0 hour into treatment. The patient¿s blood was returned, and the treatment was terminated. Cardiopulmonary resuscitative measures were executed (details not provided), and the patient received intravenous epinephrine (dosage not provided) during the code. Emergency medical services transported the patient to the hospital, where he expired (details not provided). The hdrn stated the cause of death was cardiac arrest, and confirmed the patient had a past medical history including cardiovascular disease. The esrd death notification was unavailable during the call. The hdrn stated the 2008t machine did not alarm during hd therapy, and was inspected by a technician and passed all functional compliance testing. Additional information, treatment records and medical records were requested but not provided.
 
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). The user facility reported the machine was inspected by a technician and passed all functional compliance testing. 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-conformances, 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T HEMODIALYSIS SYSTEM WITHOUT 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 Key8136863
MDR Text Key129443854
Report Number2937457-2018-03590
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100903
UDI-Public00840861100903
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113427
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190858
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 Received12/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2014
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: 12/06/2018 Patient Sequence Number: 1
-
-