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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190371
Device Problems Mechanical Problem (1384); Reflux within Device (1522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (bmt) reported that a 2008k hemodialysis (hd) machine was giving a filling program message in setup and the saline bag was filling.It was stated a saline bag backfill had occurred during priming.The bmt confirmed the drain line length and height were within specification and stated there were no quick disconnects used on the drain line.The bmt verified there was no patient involvement associated with the reported issues.The machine was in the setup process in dialysis mode when this occurred.Per bmt user error was not a contributing factor.The machine had over 55,000 hours on it at the time of the event.The bmt stated the machine software was upgraded and verified that the drain line length and height were within specification.To resolve the reported issue, the bmt replaced the air separator adapter board kit and the machine was subsequently returned to service.The used parts were not available to be returned for 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 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 (bmt) reported that a 2008k hemodialysis (hd) machine was giving a filling program message in setup and the saline bag was filling.It was stated a saline bag backfill had occurred during priming.The bmt confirmed the drain line length and height were within specification and stated there were no quick disconnects used on the drain line.The bmt verified there was no patient involvement associated with the reported issues.The machine was in the setup process in dialysis mode when this occurred.Per bmt user error was not a contributing factor.The machine had over 55,000 hours on it at the time of the event.The bmt stated the machine software was upgraded and verified that the drain line length and height were within specification.To resolve the reported issue, the bmt replaced the air separator adapter board kit and the machine was subsequently returned to service.The used parts were not available to be returned for evaluation.
 
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Brand Name
2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
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 Key12385817
MDR Text Key268779787
Report Number2937457-2021-01811
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number190371
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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