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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 03/16/2014

Event Type  malfunction  

Event Description

The home patient reported the heparin pump alarmed during hemodialysis treatment and would not deliver heparin.Subsequently, she was able to return all but "40-50" ml of her blood.The pt did not require medical intervention.The machine was serviced by the machine technician and the pt continues on home hemodialysis.Ebl: 50 ml.

Manufacturer Narrative

Based on the info provided, it is unk how the device may have caused or contributed to the event.The service technician manually checked the device components and tested the bolus function and delivery accuracy of the heparin pump module.It seemed to work well.But based on the pt's description of the problem.The heparin pump module and cable was replaced in an overabundance of caution.The plant investigation is pending and a supplemental medwatch will be submitted upon review of the investigation findings.

• Brand Name: K@HOME
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3861193
• MDR Text Key: 4460111
• Report Number: 2937457-2014-00566
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2014

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: 03/17/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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