MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K AT 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 04/11/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Investigations findings to date indicated the reported malfunction occurred during recirculation adn prime (machine set-up), and not during dialysis mode.The suer 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.

• Brand Name: 2008K AT 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: dianne chin ; 920 winter st.; waltham, CA 02451-1457 ; 7816999105
• MDR Report Key: 3952611
• MDR Text Key: 4625884
• Report Number: 2937457-2014-00808
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN SALINE (DISCARDED NOT USED)