MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA K@HOME; ONW

Catalog Number K@HOME

Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigations findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and not during dialysis mode.The user visually observed the saline bag refilling with dialysate during circulation.There have been no adverse events associated with the reported issue.The report is being investigated by the manufacturer via a capa.The investigation is pending a supplemental mdr will be filed at the completion of the investigation.

Event Description

A user facility reported a saline bag back filled during recirculation mode.A patient was not connected to the machine at the time of the incident.There were no parts replaced on the device by the technician and the machine was returned to service.

• Brand Name: K@HOME
• Type of Device: ONW
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): WALNUT CREEK; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5703278
• MDR Text Key: 47313163
• Report Number: 2937457-2016-00589
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Home Health Aide
• Device Catalogue Number: K@HOME
• Device Lot Number: 7K0S107924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• Date Device Manufactured: 11/22/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-0629-2014
• Patient Sequence Number: 1