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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2015

Event Type  malfunction  

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 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.

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
• Type of Device: ONW
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson avenu; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5350517
• MDR Text Key: 35608302
• Report Number: 2937457-2016-00002
• Device Sequence Number: 1
• Product Code: KPO
• UDI-Device Identifier: 00840861100965
• UDI-Public: 00840861100965
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 75