MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS 2008K@HOME HEMODIALYSIS SYSTEM WITH BIBAG; HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE

Catalog Number 190904

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Findings to date determined the patient's actuator board required replacing.The biomedical technician has received the new actuator board and is currently running tests on the device.A supplemental report will be filed upon completion of the plant investigation.

Event Description

A k@home hemodialysis patient's biomedical technician reported the device was removing too much fluid during treatment.The patient reported his treatment on (b)(6) 2016 resulted in ultra-filtration (uf) greater than 1,000 ml.The patient and his wife turned off the uf and the patient was given 600ml of saline to replace the lost fluids.The patient reported he was fine and had no further details to report, such as machine settings and error messages.The patient required no medical intervention.Follow-up with the patient's dialysis nurse confirmed the k@home machine pulled more than programmed amount of fluid and patient compensated by lowering uf goal.For this event, the uf goal was set at 200ml and machine pulled of greater than 1,000ml of fluid.The patient has since experienced weakness and headaches but has not required medical intervention.The patient is currently undergoing inpatient hemodialysis.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore, the failure mode cannot be confirmed.However, a records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the dhr record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: FRESENIUS 2008K@HOME HEMODIALYSIS SYSTEM WITH BIBAG
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5443994
• MDR Text Key: 38641539
• Report Number: 2937457-2016-00180
• Device Sequence Number: 1
• Product Code: ONW
• 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: consumer,health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 190904
• Other Device ID Number: 00840861100965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2015
• 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: 41 YR
• Patient Weight: 78