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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 Problems Alarm Not Visible (1022); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 04/05/2018
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
Hemodialysis clinic contact reported that when they were trying to administer iron through the venous port, the blood was coming out of the venous injection port. There was no reported patient complication. Patient did experience some blood loss, ~10cc. The dialysis treatment was discontinued. Follow up with the clinic indicates that the nurse felt that the dialysis machine was creating too much pressure which caused the leak. The dialysis machine was pulled from the floor and service was requested. Additional information was solicited.
 
Event Description
". ".
 
Manufacturer Narrative
Correction: (b)(4). 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. All functional checks passed. 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. Therefore, the complaint is not confirmed.
 
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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
MDR Report Key7462376
MDR Text Key106718572
Report Number2937457-2018-01156
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 05/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2018
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
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received05/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

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