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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K OLC ONLY WITH HEPARIN PUMP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K OLC ONLY WITH HEPARIN PUMP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008K
Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 04/11/2017
Event Type  malfunction  
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. Follow-up was provided by the biomed which revealed that the unit was removed from service for evaluation following the event. The biomed found that the rod in the air separator assembly had residue. The biomed reported that a new air separator assembly will be ordered and the cbe upgrades will be performed on this unit in response to the event, however, no further information has been made available. The current repair status of the machine is unknown. It is not currently known if the unit has been 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 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 reported event of saline bag backfilled during recirculation was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
A biomedical technician (biomed) at the user facility reported that a 2008k hemodialysis (hd) machine had displayed the filling program, high transmembrane (tmp) messages, and had fluid backfilling into the saline bag while the unit was being set-up (primed) for use. A patient was not connected to the machine at the time of the incident. Reportedly, the drain line length and height for this unit were within specification and quick disconnects are not used on the drain line. The biomed confirmed that the unit has not received the cbe hardware and software upgrades. Following the event, the unit was pulled from service for evaluation. The evaluation performed by the biomed found that the rod in the air separator had residue. The biomed reported that a new air separator assembly will be ordered and the cbe upgrades will be performed on this unit in response to the event, however, no further information has been made available. The unit remains out of service.
 
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Brand Name2008K OLC ONLY WITH HEPARIN PUMP
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 Key6555261
MDR Text Key74790769
Report Number2937457-2017-00342
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Remedial Action Notification
Type of Report Initial
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008K
Device Catalogue Number190305
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 Received04/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0629-2014

Patient Treatment Data
Date Received: 05/09/2017 Patient Sequence Number: 1
Treatment
SALINE (UNKNOWN)
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