MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190371
Medical Device Problem Code	Programming Issue (3014)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.As the serial number of the alleged machine was not provided, an investigation of the device manufacturing records could not be conducted by the manufacturer.Please be advised 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.
Event or Problem Description
It was reported by a clinical service specialist that the after the treatment parameters were entered, the ultrafiltration (uf) rate changed to 300 ml/hr and the uf time changed 3 hours.The clinical staff noticed this as it happened and corrected it.The patient completed treatment on the machine without any ill effects or adverse events.Follow-up was made with the clinic biomedical engineer, who stated the issue occurred when the machine was initially in treatment mode and confirmed there was no patient injury and no adverse event occurred.Per biomed tech the patient information and machine serial number were unknown.The biomed tech stated the issue was resolved by having the machine turned off and turned back on.The biomed tech stated no components or repairs were needed, and the machine remained in use without further issue.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 6904702
• Report Number: 2937457-2017-00977
• Device Sequence Number: 1026418
• Product Code: KDI
• UDI-Device Identifier: 00840861100866
• UDI-Public: 00840861100866
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K994267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2017

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: Health Professional
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1