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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 OLC ONLY WITH HEPARIN PUMP
Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 12/23/2016
Event Type  malfunction  
Manufacturer Narrative
Investigations findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and not during dialysis mode. The user visually observed the saline bag refilling with dialysate during circulation. 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 facility biomedical technician (biomed) reported that a saline bag back filled while the unit was serviced. The machine was giving alternating alarm messages of tmp and filling program at the time of the event. There were no audible alarms because the audible alarms (when lines off shunt) option was turned off in service mode. The biomed was not able to confirm if the tmp alarm messages were high or low or what the value was. Most current software upgrades had not been completed on this machine at the time of the event. Follow-up information provided by the biomed revealed that the air separator was replaced which resolved the issue. The unit has been returned to service at the user facility without a recurrence of the reported issue.
 
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 provided by the biomed revealed that the air separator was replaced which resolved the issue. The unit has been returned to service at the user facility without a recurrence of the reported issue. 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.
 
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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 Key6239124
MDR Text Key64433389
Report Number2937457-2017-00023
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,Followup
Report Date 02/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Biomedical Engineer
Device Model Number2008K OLC ONLY WITH HEPARIN PUMP
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 Received02/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2007
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: 01/10/2017 Patient Sequence Number: 1
Treatment
UNKNOWN SALINE (DISCARDED-NOT USED)
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