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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 191130
Device Problem Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2023
Event Type  malfunction  
Event Description
A fresenius field service technician (fst) was called onsite by a biomedical technician (biomed) at a user facility who reported that the fresenius 2008t hemodialysis (hd) machine experienced a power surge.The biomed was not present for the reported event but the facility staff observed arcing.There was no observed smoke, spark, flame, or other visual indications of thermal damage.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The fst replaced the power supply.The machine has approximately 1,837 hours and the power supply was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the power supply.The unit was returned to service at the user facility without issue and without reoccurrence of the event.No parts were reported to be available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
A fresenius field service technician (fst) was called onsite by a biomedical technician (biomed) at a user facility who reported that the fresenius 2008t hemodialysis (hd) machine experienced a power surge.The biomed was not present for the reported event but the facility staff observed arcing.There was no observed smoke, spark, flame, or other visual indications of thermal damage.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The fst replaced the power supply.The machine has approximately 1,837 hours and the power supply was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the power supply.The unit was returned to service at the user facility without issue and without reoccurrence of the event.No parts were reported to be available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Plant investigation: although it was stated that the complaint device was available to be returned, to date 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 found objective evidence indicating a product problem, thus the complaint is confirmed.
 
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Brand Name
2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
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 Key18435641
MDR Text Key331791123
Report Number0002937457-2024-00004
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102112
UDI-Public00840861102112
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
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 01/31/2024
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 Number191130
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 12/29/2023
Initial Date FDA Received01/03/2024
Supplement Dates Manufacturer Received01/30/2024
Supplement Dates FDA Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2020
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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