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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008T
Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/16/2017
Event Type  malfunction  
Manufacturer Narrative
No parts have been returned to the manufacturer for physical evaluation. There have been no adverse events associated with the reported issue. The 2008t hemodialysis (hd) machine was evaluated at the facility by a fresenius regional equipment specialist (res). Machine functional checks were performed. No system issues were identified during the on-site evaluation. The res could not duplicate the problem and confirmed that the unit was operating properly. No malfunction of the 2008t hd machine observed or identified during the on-site evaluation. The unit remains out of service pending approval from the facility management. No further information has been made available. 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 found during the manufacturing process which could be associated with the reported event. In addition, the review of the in-progress and final quality control testing of the device confirmed that the results were within specification. The reported event of saline bag backfilled during recirculation was not able to be confirmed. Functional testing performed by the res confirmed that the system was operating properly. Therefore, the complaint has been deemed not confirmed.
 
Event Description
A biomedical engineer (biomed) at the user facility reported that a 2008t hemodialysis (hd) machine had fluid backfilling into the saline bag while the unit was being set-up (prime) for use. A patient was not connected to the machine at the time of the incident. Reportedly, a staff member observed the solution backfill into the saline bag approximately thirty minutes into the set-up. The biomed confirmed that the unit had received the cbe hardware and software upgrades in july 2016. Following the event, the unit was pulled from service for evaluation. A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine. The res confirmed that there were no leaks or hydraulic pressure issues. The res could not duplicate the problem and confirmed that the unit was operating properly. The unit remains out of service pending approval from the facility management. No further information has been made available.
 
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Brand Name2008T GEN 2 BIBAG WITHOUT 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 Key6419050
MDR Text Key70421941
Report Number2937457-2017-00184
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008T
Device Catalogue Number190895
Other Device ID Number00840861100927
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 Received02/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/20/2017 Patient Sequence Number: 1
Treatment
SALINE (UNKNOWN)
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