• 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 SYS., WITH 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 SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008T
Device Problems Fluid Leak (1250); Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2016
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility reported that the "dialysate hose ruptured" on a 2008t hemodialysis (hd) machine while a patient was undergoing a routinely scheduled hd treatment. Reportedly, the patient inadvertently moved the machine while dialyzing, and by doing so, caused the dialysate tubing to "snap off," which led to dialysate "going everywhere. " the patient was disconnected from the system, and then re-setup on another machine to complete the hd treatment. The blood within the extracorporeal circuit was not returned to the patient. The patient's estimated blood loss (ebl) was noted as being approximately 250ml. No patient adverse effects were experienced and no medical intervention was required as a result of this event. Following the event, the 2008t hd machine was removed from service for evaluation. The dialysate hose was removed and was found to be visibly damaged. The biomedical technician replaced the dialysate hose on the 2008t hd machine to resolve the issue. The unit has been returned to service at the user facility without a recurrence of the event as reported. No parts are available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis. The biomedical technician provided follow-up information which revealed that the 2008t hd machine was removed from service for evaluation following the event. The dialysate hose was removed and was found to be visibly damaged. The biomed replaced the dialysate hose to resolve the issue. The unit has been returned to service at the user facility without a recurrence of the event as reported. 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 deviations or non-conformances during the manufacturing process which could be associated with the reported event. In addition, the device history record (dhr) review confirmed the material and process controls were within specification. 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 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 Key6254822
MDR Text Key64951717
Report Number2937457-2017-00035
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 company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008T
Device Catalogue Number190713
Other Device ID Number00840861100897
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-