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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG; HEMODIALYSIS SYSTEM FOR HOME USE
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CONCORD MANUFACTURING 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG; HEMODIALYSIS SYSTEM FOR HOME USE Back to Search Results
Catalog Number 190904
Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/03/2017
Event Type  malfunction  
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient reported during recirculation mode the saline bag was visibly seen backfilling with solution.The biomed tech stated he went to the patient¿s home to examine the machine and performed machine checks and could not duplicate the issue and no issues were determined.Per biomed tech the machine passed all functional checks (fc) and the patient was able to continue on with hemodialysis treatment without issue.The biomed tech stated the machine did have the cbe upgraded before the saline bag backfilled and prior to the incident but was unable to provide an exact date.No repairs were needed.The biomed tech declined any res services and stated the machine remained in use without further issue.No parts were available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.
 
Event Description
A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient reported during recirculation mode the saline bag was visibly seen backfilling with solution.The biomed tech stated he went to the patient¿s home to examine the machine and performed machine checks and could not duplicate the issue and no issues were determined.Per biomed tech the machine passed all functional checks (fc) and the patient was able to continue on with hemodialysis treatment without issue.The biomed tech stated the machine did have the cbe upgraded before the saline bag backfilled and prior to the incident but was unable to provide an exact date.No repairs were needed.The biomed tech declined any res services and stated the machine remained in use without further issue.No parts were available to be returned to the manufacturer for evaluation.
 
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Brand Name
2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
Type of Device
HEMODIALYSIS SYSTEM FOR HOME USE
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7004627
MDR Text Key92212451
Report Number2937457-2017-01144
Device Sequence Number1
Product Code ONW
UDI-Device Identifier00840861100965
UDI-Public00840861100965
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K124035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number190904
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age MO
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2016
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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