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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190618
Device Problem Inadequate Ultra Filtration (1656)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2023
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 reported to fresenius mexico that a 2008k2 machine does not ultrafilter what is programmed.The machine had broken check valves which caused the ultrafiltration (uf) pump not to run what is programmed.The broken check valves were replaced to resolve the reported issue.The uf pump sections were calibrated (to 24 ml/min).The machine passed functional testing.There was patient involvement however no patient harm was reported.The patient was able to complete treatment on the same machine with the same disposables.No parts have been returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Correction: d8 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.It was determined during the investigation that there is a causal relationship between the objective evidence and the alleged event; therefore the alleged event is confirmed.
 
Event Description
A user facility reported to fresenius mexico that a 2008k2 machine does not ultrafilter what is programmed.The machine had broken check valves which caused the ultrafiltration (uf) pump not to run what is programmed.The broken check valves were replaced to resolve the reported issue.The uf pump sections were calibrated (to 24 ml/min).The machine passed functional testing.There was patient involvement however no patient harm was reported.The patient was able to complete treatment on the same machine with the same disposables.No parts have been returned to the manufacturer for physical evaluation.
 
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Brand Name
2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH
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 Key16307815
MDR Text Key308954271
Report Number0002937457-2023-00173
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K153449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/09/2023
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 Number190618
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 01/23/2023
Initial Date FDA Received02/06/2023
Supplement Dates Manufacturer Received03/01/2023
Supplement Dates FDA Received03/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2011
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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