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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING UNKNOWN-2008 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number UNKNOWN-2008
Device Problems Inadequate Ultra Filtration (1656); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2022
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius field service technician (fst). A records review was not performed as the serial number was not reported. The investigation into the cause of the reported problem 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
A user facility biomedical technician (biomed) reported to a fresenius clinical support specialist that a 2008 machine (model unknown) which was recently upgraded with bluestar software is not holding the programmed ultrafiltration (uf) goal and time settings. The settings were programmed to a uf goal of 2. 5 liters and a uf time of 4 hours. The biomed stated that a second person visually verified the programmed settings to ensure that they were correct. However a few minutes after the initiation of treatment the machine reverts back to the default settings of 3 liters and 3 hours. Additional information was requested, however a response has not been received. There was no indication that the patient experienced a serious injury, adverse event, or required medical intervention as a result of the reported issue. It was indicated on the initial report that the patient was not able to complete treatment with the fresenius products and devices that were originally provided. No parts were returned to the manufacturer for a physical evaluation.
 
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Brand NameUNKNOWN-2008
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key14251531
MDR Text Key290397945
Report Number0002937457-2022-00707
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 05/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-2008
Device Catalogue NumberUNKNOWN- 2008T MACHINE
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received05/03/2022
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 Initial

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