MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS LIBERTY CYCLER; PERITONEAL DIALYSIS SYSTEM

Model Number LIB

Device Problem Insufficient Information (3190)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 07/14/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, a peritoneal dialysis pt called fresenius tech support regarding fill complications.The pt was in fill 1 with 1293ml expected 2500ml when she was getting fill complication alarm and the pt stated she just came home from the hosp, she was there for 3 days because she had too much solution that was not draining out.The last day, she did treatment was on (b)(6) 2012 and she stopped using the cycler because she stated it stopped pumping.Tech support replaced the cycler and advised to discontinue use of the cycler and f/u with her peritoneal dialysis nurse.

Manufacturer Narrative

A product investigation was performed for the device.The actual device was not returned for eval.A review of the device history record was performed.There was no unexpected variances, adjustments or comments noted in the device record.A review of the complaint tracking system listed no other complaints for this device.A review was performed by the post market clinical dept.Per the parmacovigilance physician, the pt was hospitalized for malignant hypertension requiring iv nitro drips due to pt's admitted non-compliance with home medications.Review of the pt's records indicate her last dialysis treatment using the cycler was ten days prior to the hospital admission and 20 days prior to her call for tech support.Although the pt states that the cycler is in part the reason for her fluid overload, there is no report of device malfunction or treatment data (either on the cycler or manual).While fluid overload may have contributed to her hypertension, it is most likely that her non-compliance with her medicines (for over one month) is the cause of her malignant hypertension requiring hospitalization.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events received between 03/21/2011 to 03/11/2013.

• Brand Name: FRESENIUS LIBERTY CYCLER
• Type of Device: PERITONEAL DIALYSIS SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer Contact: tanya taft ; 920 winter st; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4112635
• MDR Text Key: 17259371
• Report Number: 2937457-2014-02681
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 07/14/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention