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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS 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 12/27/2016
Event Type  malfunction  
Manufacturer Narrative
Investigation findings to date indicated the reported malfunction occurred during prime (machine set-up), and not during dialysis mode. The user visually observed the saline bag refilling with dialysate during prime. There have been no adverse events associated with the reported issue. The report is being investigated by the manufacturer via a capa. Plant investigation is in process. A supplemental mdr will be submitted upon the completion of this activity.
 
Event Description
A biomedical engineer (biomed) at the user facility reported a saline bag backfilled during setup mode. Reportedly, the staff observed the saline bag had inflated during priming of the machine. A patient was not connected to the machine at the time of the incident. The biomed confirmed that the unit has not received the cbe hardware and software upgrades. Following the event, the machine was pulled from service and the biomed ordered the parts necessary to complete the cbe upgrades. The unit remains out of service and will be returned to the floor following the completion of the cbe upgrade. 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 performed the cbe upgrade which resolved the issue. Functional testing performed by the biomed confirmed the system was operating properly. 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. The reported event of saline bag backfilled during setup 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
Follow-up was provided by the biomed who revealed that the cbe upgrade was performed to resolve the reported event of saline bag backfilled. Functional testing performed by the biomed confirmed the system was operating properly. The unit has been returned to service at the user facility without a recurrence of the event as reported.
 
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Brand Name2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
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 johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6264187
MDR Text Key65276814
Report Number2937457-2017-00050
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,health
Reporter Occupation Biomedical Engineer
Remedial Action Notification
Type of Report Initial,Followup
Report Date 02/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008K
Device Catalogue Number190371
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 Received01/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2006
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: 01/19/2017 Patient Sequence Number: 1
Treatment
SALINE (UNKNOWN)
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