MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP

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

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

A user facility reported on behalf of a home hemodialysis pt a saline bag back fill during priming while setting up the device.It was reported the drain bag had 500ml of fluid while the saline bag had 950ml of fluid remaining which was more than expected.The pt had not yet begun treatment and was not connected to the device.The pt called technical support for assistance and a technologist visited the patient's home.The technologist discovered evidence of a partial restriction on the drain hose at the home's standing drain.The hose was kinked on the top edge of the drain pipe.The drain hose was adjusted into a vertical loop and tied into place to prevent restriction in the future.The machine was tested and passed priming without further issue.Inspection of the machine did not reveal nay further faults.There is no adverse event associated with this incident.

Manufacturer Narrative

Investigation findings to date indicate 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 this reported issue.This 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.

• Brand Name: 2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3727241
• MDR Text Key: 4278576
• Report Number: 2937457-2014-00137
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Type of Report: Initial
• Report Date: 01/14/2014

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2011
• 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
• Treatment: UNK SALINE (DISCARDED - NOT USED)