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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190610
Device Problems Mechanical Problem (1384); Reflux within Device (1522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2022
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 biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a saline bag backfill during the recirculation phase of setup.The backfill was visually observed by the nursing staff.The bag that was primed to fill with 500 ml filled to approximately 1000 ml.A patient was not connected to the machine at the time of the incident.The biomed reported that there were no quick disconnects on the drain line and that the drain line length and height were within specification.The biomed believes the saline bag backfill was not due to user error.It was confirmed that the unit has received the cbe hardware and software upgrades.The biomed stated that the machine will not be repaired due to age and cost of repairs.The machine has been removed from service permanently.
 
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.The manufacturer was able to determine during their investigation a causal relationship between the objective evidence and the alleged event; the alleged event is confirmed.
 
Event Description
A biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a saline bag backfill during the recirculation phase of setup.The backfill was visually observed by the nursing staff.The bag that was primed to fill with 500 ml filled to approximately 1000 ml.A patient was not connected to the machine at the time of the incident.The biomed reported that there were no quick disconnects on the drain line and that the drain line length and height were within specification.The biomed believes the saline bag backfill was not due to user error.It was confirmed that the unit has received the cbe hardware and software upgrades.The biomed stated that the machine will not be repaired due to age and cost of repairs.The machine has been removed from service permanently.
 
Manufacturer Narrative
Correction: h10 (plant investigation: removed statement that event was not confirmed) 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 manufacturer was able to determine during their investigation a causal relationship between the objective evidence and the alleged event; the alleged event is confirmed.
 
Event Description
A biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a saline bag backfill during the recirculation phase of setup.The backfill was visually observed by the nursing staff.The bag that was primed to fill with 500 ml filled to approximately 1000 ml.A patient was not connected to the machine at the time of the incident.The biomed reported that there were no quick disconnects on the drain line and that the drain line length and height were within specification.The biomed believes the saline bag backfill was not due to user error.It was confirmed that the unit has received the cbe hardware and software upgrades.The biomed stated that the machine will not be repaired due to age and cost of repairs.The machine has been removed from service permanently.
 
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Brand Name
2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
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 Key15008261
MDR Text Key304462335
Report Number0002937457-2022-01174
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100859
UDI-Public00840861100859
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
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,Followup
Report Date 08/02/2022
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 Model Number190610
Device Catalogue Number190610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 06/29/2022
Initial Date FDA Received07/13/2022
Supplement Dates Manufacturer Received07/13/2022
08/01/2022
Supplement Dates FDA Received08/01/2022
08/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2009
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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