MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG; HEMODIALYSIS SYSTEM FOR HOME USE

Catalog Number	190904
Medical Device Problem Codes	Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
• Common Device Name: HEMODIALYSIS SYSTEM FOR HOME USE
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7004627
• Report Number: 2937457-2017-01144
• Device Sequence Number: 18962424
• Product Code: ONW
• UDI-Device Identifier: 00840861100965
• UDI-Public: 00840861100965
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K124035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 190904
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1