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

Model Number LIB

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem Peritonitis (2252)

Event Date 05/18/2012

Event Type  Injury  

Event Description

A peritoneal dialysis pt called fresenius tech support stating she was just released from a 10 day stay in the hosp with peritonitis and she was confused about the operation of the cycler.The pt said this was the second setup and they encountered an m01.17 alarm for insufficient fluid in heater bag message.They detached the heater bag and re-attached a new one.The pt also skipped their pause and got confused.At the time of call the pt was disconnected and the cycler was off.Tech support staff provided guidance to the pt for addressing the alarm issues.By the end of the call, the pt was okay and calm and ready to complete treatment on her own.

Manufacturer Narrative

A product investigation was performed for the device.A simulated treatment was performed and completed without any failures or problems.The reported m01.17 alarm was not duplicated or verified.There was no evidence of fluid leaks found during visual inspection.All functional tests passed.A review of the device history records was performed and there were no unexpected variances, or adjustments, or comments noted in the device records.A search of the complaint tracking system showed one other complaint for m01.17 alarm during setup for this device, however, trending plan thresholds are not triggered.The clinical investigation indicates the pt's peritoneal dialysis nurse stated the peritonitis was due to touch contamination rather than the use of the cycler and there were no reported cassette fluid leaks.The peritonitis occurred on (b)(6) 2012 which was 15 days prior to the tech support call.The pt was treated with antibiotics for 8 days and then released from the hosp.The clinical investigation concludes peritonitis is typically due to touch contamination of the peritoneal dialysis catheter/tubing connection and not attributed to the cycler.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 CYCLER
• 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 ; 920 winter st; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4059087
• MDR Text Key: 4865891
• Report Number: 2937457-2014-02216
• 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: 05/19/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: No
• 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: 05/19/2012
• 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): Death; Hospitalization
• Patient Age: 65 YR
• Patient Weight: 82