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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
Catalog Number 190713
Device Problem Inadequate Ultra Filtration (1656)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2024
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
It was reported to fresenius technical services that treatment on the 2008t machine ended five minutes early.The machine will start correctly and slowly lose time over the course of treatment.This issue affects both the ultrafiltration (uf) time and treatment end time.There are no diagnostic messages or audible alarms associated with the reported issue.The patient was able to complete treatment.There was no adverse event, serious injury, or required medical intervention as a result of the reported issue.The fresenius technical services representative explained that the treatment end time on the trends screen corresponds with the remaining time to dialyze (rtd) on the home screen.Any changes to rtd will affect treatment end time.Then technical services referred the customer to the regional sales manager to be put in touch with the local clinical consultant.The customer was advised to swap the function board if the clinical consultant could not assist and this machine continued to experience this issue.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.
 
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 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 identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The complaint investigation did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.
 
Event Description
It was reported to fresenius technical services that treatment on the 2008t machine ended five minutes early.The machine will start correctly and slowly lose time over the course of treatment.This issue affects both the ultrafiltration (uf) time and treatment end time.There are no diagnostic messages or audible alarms associated with the reported issue.The patient was able to complete treatment.There was no adverse event, serious injury, or required medical intervention as a result of the reported issue.The fresenius technical services representative explained that the treatment end time on the trends screen corresponds with the remaining time to dialyze (rtd) on the home screen.Any changes to rtd will affect treatment end time.Then technical services referred the customer to the regional sales manager to be put in touch with the local clinical consultant.The customer was advised to swap the function board if the clinical consultant could not assist and this machine continued to experience this issue.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.
 
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Brand Name
2008T HEMODIALYSIS SYS., WITH CDX
Type of Device
DIALYZER, 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key19218465
MDR Text Key341516700
Report Number0002937457-2024-00706
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
Report Date 05/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 04/10/2024
Initial Date FDA Received04/30/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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