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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HD SYS. CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191124
Device Problems Fluid/Blood Leak (1250); Inadequate Ultra Filtration (1656); Inadequate Filtration Process (2308)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
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 user facility biomedical technician (biomed) reported that the fresenius 2008t machine pulled more fluid during ultra filtration (uf) than the programmed amount.During follow-up the biomed reported that the machine was pulled from service and inspected.The uf pump was found to be out of calibration and was recalibrated to resolve the issue.The machine passed functional testing and was returned to service.The nurse manager confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.Additional details were requested, however a response was not received.
 
Manufacturer Narrative
Correction: b7, h6 (medical device problem code).
 
Event Description
A user facility biomedical technician (biomed) reported that the fresenius 2008t machine pulled more fluid during ultra filtration (uf) than the programmed amount.During follow-up the biomed reported that the machine was pulled from service and inspected.The uf pump was found to be out of calibration and was recalibrated to resolve the issue.The machine passed functional testing and was returned to service.The nurse manager confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.Additional details were requested, however a response was not received.
 
Manufacturer Narrative
Correction: h6 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 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 that the fresenius 2008t machine pulled more fluid during ultra filtration (uf) than the programmed amount.During follow-up the biomed reported that the machine was pulled from service and inspected.The uf pump was found to be out of calibration and was recalibrated to resolve the issue.The machine passed functional testing and was returned to service.The nurse manager confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.Additional details were requested, however a response was not received.
 
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Brand Name
2008T HD SYS. CDX 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
MDR Report Key11656024
MDR Text Key246687441
Report Number2937457-2021-00666
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102082
UDI-Public00840861102082
Combination Product (y/n)N
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 05/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number191124
Device Catalogue Number191124
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received04/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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