MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K@HOME HEMODIALYSIS SYSTEM W/BIBAG; ONW

Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts were returned to the manufacturer for physical evaluation and the plant investigation is on-going.A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during a dialysis treatment, a home hemodialysis pt had been on the machine for 4.5 hours before receiving an air detector alarm.The pt could not clear the air detector alarm and noticed air in the bloodline.The pt was unable to return her blood.There was an estimated blood loss of 50cc.The pt did not experience any adverse effects.A fresenius regional equipment specialist replaced the level detector module which resolved the issue.The pt was able to continue her normal dialysis treatment schedule and did not miss any treatments.
Additional Manufacturer Narrative
A fresenius regional equipment specialist (res) performed an on-site investigation and the failure mode was confirmed.During field service investigation the venous line clamp would not open to allow the machine to prime.The problem was resolved by replacing the level detector module.During investigation of the machine the temperature was found to be high.The temperature problem was resolved by calibrating the temperature control.The level detector module was replaced which resolved the issue.The device was returned to service with no further issues.An investigation of the dev ice manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

• Brand Name: 2008K@HOME HEMODIALYSIS SYSTEM W/BIBAG
• Common Device Name: ONW
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• MDR Report Key: 5350517
• Report Number: 2937457-2016-00002
• Device Sequence Number: 508461
• Product Code: KPO
• UDI-Device Identifier: 00840861100965
• UDI-Public: 00840861100965
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K124035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date (Section B): 01/04/2016

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2016
• Supplement Report FDA Received Date: 02/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 75