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

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

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2013

Event Type  malfunction  

Event Description

It was reported by the home dialysis patient in (b)(6) that the saline bag was found back-filling during priming phase.The patient was not involved in the incident.The patient also reported that the machine had tmp problems and alarmed appropriately.

Manufacturer Narrative

Investigation findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and typically not during dialysis mode.The saline bag refilling with dialysate was generally observed visually during recirculation.The manufacturer sent a service technician to the home to service the machine.The technician replaced the uf check valves due to wear and reported that the drain hose was partially occluded where it entered the drain.Once the occlusion was resolved the issue could not be duplicated.There have been no adverse events associated with the reported issue.The report is being investigated by the manufacturer via a capa.

• Brand Name: 2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP
• Type of Device: ONW
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): WALNUT CREEK PLANT; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft,rn cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4934803
• MDR Text Key: 16070593
• Report Number: 2937457-2015-01278
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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