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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2017
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. Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event. An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the 2008t hemodialysis (hd) machine in question was not known, therefore, the serial number was not able to be provided. However, all device history records (dhr) are reviewed and released according to the "dhr review checklist & release procedure. " p/n 500658; a device is not released if it does not meet requirements or is nonconforming. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
A social media post stated that a 2008t hemodialysis (hd) machine had saline bag backfilled with a patient connected to the machine. It was noted that the saline bag was inflated an hour into treatment. No blood was observed in the bag. There was no harm or adverse event reported. No parts were available to be returned to the manufacturer for evaluation.
 
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Brand Name2008T MACHINE
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 Key6644117
MDR Text Key77660839
Report Number2937457-2017-00470
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 06/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received06/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

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