MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS 2008K@HOME

Catalog Number 190395

Device Problems Device Operates Differently Than Expected (2913); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be filed upon completion of the plant investigation.

Event Description

A home dialysis pt called the mfr to report she was having problems with the venous pressure lines.The pt reported she had started treatment when the venous pressure read zero.She set up a new venous line and the venous pressure continued to read zero.She set up new needle and noticed that the blood in the venous side was back.The pt returned her blood on the arterial side and reports a blood loss of less than 200cc from venous side.Pt discarded tubing.The pt did not continue her hemodialysis until the next day.On (b)(6) 2015, she reports the treatment on (b)(6) 2015 was without event and ran as expected.

Manufacturer Narrative

Device review: the pt did not request service from the mfr's regional equipment specialist.After several requests, the pt did not provide the serial number of the machine.As a result, a device history record review could not be performed.All device history records (dhr) are reviewed and released according to "dhr review checklist and release procedure".A device is not released if it does not meet requirements or is non-conforming.The pt's biomedical technician reported that there were no problems with the machine.The pt's home therapies rn reported that the pt had no further problems with her treatments following the event.

Manufacturer Narrative

Device review: the complaint device is unavailable for investigation.A device history record review was performed which included labeling reconciliation, material/component traceability, non-conformance's and/or any associated rework potentially related to the reported complaint, scrap rates, environmental controls, results on in-process and final qc testing, process controls.The review found the k@home device was manufactured to specifications with no unexpected variances or adjustments.The patient's biomedical technician reported there was no problem with the patient's machine.The patient's rn has reported that treatments have run without any problems since this event.

• Brand Name: FRESENIUS 2008K@HOME
• 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 taft, rn, cnor ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5357114
• MDR Text Key: 35988324
• Report Number: 2937457-2016-00011
• 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: consumer
• Type of Report: Initial
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 190395
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2007
• 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
• Patient Age: 62 YR