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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 HEMODIALYSIS SYS., WITH CDX
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2016
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in progress. A supplemental medwatch will be submitted upon the completion of this activity.
 
Event Description
The user facility reported that a low trans membrane pressure (tmp) alarm was generated by the 2008t hemodialysis (hd) machine while a patient underwent a routinely scheduled hd treatment. Reportedly, this resulted in blood backing up into the venous pressure transducer. The patient's estimated blood loss (ebl) was noted as being approximately 10 milliliters (ml). No patient adverse effects were experienced and no medical intervention was required as a result of this event. Following the event, the 2008t hd machine was removed from service and evaluated by the facility biomedical technician (biomed). The venous pressure calibration failed functional testing. The biomed replaced the venous internal transducer and line which resolved the issue. Functional testing performed by the biomed confirmed that the system was operating properly. The unit has been returned to service at the user facility without a recurrence of the event as reported.
 
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 unit was removed from service for evaluation following the event. The venous pressure calibration failed functional testing. The biomed replaced the venous internal transducer and line 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. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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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 Key6239105
MDR Text Key64433047
Report Number2937457-2017-00024
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 02/23/2017
1 Device was Involved in the Event
0 Patients were 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
Device Model Number2008T HEMODIALYSIS SYS., WITH CDX
Device Catalogue Number190713
Other Device ID Number00840861100897
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 Received02/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2015
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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