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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
Model Number 2008T
Device Problem Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2017
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res). The res inspected the rollers, tubing guides, and tubing retainer/release, which were intact and functioning properly. The res verified pumping flow and verified that the tubing set could be removed and replaced multiple times without any issues. The user facility biomedical technician (biomed) informed the res that the tubing retainer/release was replaced prior to the res inspection. The unit is reportedly approved to be returned to service at the user facility. 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 associated with 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. The res verified that the machine was operating properly as the biomed reportedly replaced the tubing retainer/release prior to res inspection of the machine. Therefore, the complaint is not confirmed.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported that the patient experienced blood loss while undergoing hemodialysis (hd) treatment on a 2008t hd machine. The biomed reported that the blood pump tubing segment was pulled up into the blood pump, wrapped around the rotor and tore. The total estimated blood loss (ebl) was noted as being approximately one unit of blood. The hd treatment was discontinued approximately six minutes early. There was no blood observed on the blood pump tubing holder. Following the event the system was removed from service for evaluation. A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine. The res inspected the rollers, tubing guides, and tubing retainer/release, which were intact and functioning properly. The res verified pumping flow and verified that the tubing set could be removed and replaced multiple times without any issues. The biomed informed the res that the tubing retainer/release was replaced prior to the res inspection. The unit is reportedly approved to be returned to service at the user facility. No parts are reported to be available to be returned to the manufacturer for evaluation. No further information has been made available at this time.
 
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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 Key6724699
MDR Text Key162947826
Report Number2937457-2017-00595
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 08/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008T
Device Catalogue Number190713
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 Received07/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/21/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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