MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MFG LIBERTY DIALYSIS CYCLER

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

Patient Problem Colostomy (2552)

Event Date 12/15/2014

Event Type  Injury  

Event Description

A peritoneal dialysis nurse (pdrn) reported a dialysis pt developed peritonitis on (b)(6) 2014 and re-current peritonitis on (b)(6) 2015.Pdrn stated the pt had peritonitis, negative staphylococcus on (b)(6) 2014 due to tough contamination and was administered the first does of vancomycin.Pt was not hospitalized.Pt developed re-current peritonitis, negative staphylococcus on (b)(6) 2015 and got antibiotics.Cell count came back negative on (b)(6) 2015 and pt's effluent was clear.The peritonitis has resolved.The pt was treated for peritonitis on (b)(6) 2014 and continued on the intra-peritoneal antibiotics through (b)(6) 2014.On (b)(6) 2015, the pt experienced abdominal pain.On (b)(6) 2015, the pt was administered vancomycin.On (b)(6) 2015, the pt's peritoneal dialysis fluid culture was hazy and set for cell count culter.The pt's culter returned positive for peritonitis and antibiotics were continued.

Manufacturer Narrative

Based on review of the medical records and other info, it was found that this is a pt with history of esrd on home peritoneal dialysis using the liberty cycler.Reportedly, the pt suffered an event of peritonitis, uncomplicated, and treated as an outpatient.Based on the 3 pages of medical records info it appears that this pt was treated for recurrent episodes of peritonitis that started on (b)(6) 2014.The pt was prescribed antibiotics that concluded (b)(6) 2014.On (b)(6) 2015, the pt started experiencing abdominal pain and the pt was treated for recurrent peritonitis.According to the peritoneal dialysis rn, the pt was diagnosed with negative staphylococcus in both episodes.There is no documentation in the medical records confirming the pt's peritonitis resolved between each episode.According to the peritoneal dialysis rn, the peritonitis is a result of tough contamination.There is no documentation in the medical record that indicates a casual relationship between the liberty cycler and the diagnosis of peritonitis.The device was not returned to the mfr for physical eval and the failure mode cannot be confirmed.However, an investigation of the device mfg records was conducted by the mfr.There was no deviations or nonconformances during the mfg process.In addition, the batch record review confirmed the labeling, material and process controls were within spec.

• Brand Name: LIBERTY DIALYSIS CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MFG; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn ; 920 winter st; waltham, MA 02451-1457 ; 8006621237
• MDR Report Key: 4605200
• MDR Text Key: 20362551
• Report Number: 2937457-2015-00348
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• 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
• Treatment: PD SOLUTIONS; EPOGEN; SENSIPAR; TURNS; FLAGYL; VANCOMYCIN; LIBERTY DIALYSIS TUBING
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR