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

Model Number LIB

Device Problem Occlusion Within Device (1423)

Patient Problem Peritonitis (2252)

Event Date 05/06/2012

Event Type  Injury  

Event Description

A peritoneal dialysis patient called fresenius technical support regarding drain complications.The patient stated that he is in drain 1 of 4.He has drained 1375ml out of 1999ml.Before technical support could go into troubleshooting with the patient, the patient disclosed that he has spoken to his peritoneal dialysis nurse regarding another medical situation he is experiencing regarding his genital area.The patient wanted to know if he should go the emergency room.Technical support strongly advised the patient to contact his peritoneal dialysis nurse for further advice.Technical support advised the patient to call back if further assistance is needed with this cycler.

Manufacturer Narrative

A product investigation was performed for this device, a visual inspection was performed.No dried fluid was visible inside of the cassette door.A simulated treatment was performed and completed without any drain complication warning encountered.All functional tests passed.A review of the device history record showed no unexpected variances, adjustment or comments in the device records.A search of the complaint tracking system listed one other complaint for this device showing the same symptom code involving a different patient.Event data will be trended per quality data analysis procedures.A medical review was performed on the available information and the cause of the event is undetermined.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 (b)(4) 2011 to (b)(4) 2013.

• Brand Name: FRESENIUS LIBERTY CYCLER
• Type of Device: PERITONEAL DIALYSIS SYSTEM, FKX
• 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 ; 920 winter street; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4060058
• MDR Text Key: 16177720
• Report Number: 2937457-2014-02003
• 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: 05/06/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• 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?: Yes
• Date Manufacturer Received: 05/06/2012
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 81 YR
• Patient Weight: 71