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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 191126
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A biomedical technician (bmt) reported to technical support that a 2008t machine will not power on.The bmt stated that he replaced the bibag box 2 board and cable to resolve the reported issue, the bmt stated that the board and the cable were fried, he commented that the cable was melted and had an electrical smell, there were no sparks.Machine was returned to service and the faulty part was discarded, there are no samples available.It was confirmed there was no patient involved, harm or adverse events reported with this incident.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.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 investigation into the cause of the reported problem was able to be confirmed.
 
Event Description
A biomedical technician (bmt) reported to technical support that a 2008t machine will not power on.The bmt stated that he replaced the bibag box 2 board and cable to resolve the reported issue, the bmt stated that the board and the cable were fried, he commented that the cable was melted and had an electrical smell, there were no sparks.Machine was returned to service and the faulty part was discarded, there are no samples available.It was confirmed there was no patient involved, harm or adverse events reported with this incident.
 
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Brand Name
2008T HD SYS. 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 Key18293042
MDR Text Key330062829
Report Number0002937457-2023-01848
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102099
UDI-Public00840861102099
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,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/02/2024
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 Other
Device Catalogue Number191126
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 12/07/2023
Initial Date FDA Received12/08/2023
Supplement Dates Manufacturer Received01/02/2024
Supplement Dates FDA Received01/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2019
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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