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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 12/16/2022
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
It was reported to fresenius mexico that a 2008k2 hemodialysis (hd) machine removed more fluid than expected from a patient.Specifically, the report to technical support (ts) stated ¿extra ultrafiltration (uf) to the patient during treatment¿ had occurred.There was no patient harm reported.The patient was able to complete treatment on the machine with the same disposables.Following the event, the equipment was checked.An adjustment and calibration of the uf pump was carried out, and tests were run.It was reported that the equipment remains working.No parts were available to be returned for manufacturer evaluation.Attempts were made to obtain more information, but no additional details could be provided.
 
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).The investigation determined there was no causal relationship between the objective evidence provided by the customer and the reported event.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
It was reported to fresenius mexico that a 2008k2 hemodialysis (hd) machine removed more fluid than expected from a patient.Specifically, the report to technical support (ts) stated ¿extra ultrafiltration (uf) to the patient during treatment¿ had occurred.There was no patient harm reported.The patient was able to complete treatment on the machine with the same disposables.Following the event, the equipment was checked.An adjustment and calibration of the uf pump was carried out, and tests were run.It was reported that the equipment remains working.No parts were available to be returned for manufacturer evaluation.Attempts were made to obtain more information, but no additional details could be provided.
 
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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 Key16113921
MDR Text Key308653213
Report Number0002937457-2023-00029
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2023
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
Device AgeMO
Date Manufacturer Received01/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2012
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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