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

Catalog Number RTLR180111

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

Patient Problems Sepsis (2067); Peritonitis (2252)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon final review of medical records by post market clinical staff and completion of plant's investigation.

Event Description

A peritoneal dialysis patient called tech services and reported having a touch contamination peritonitis and was being treated.Medical records were received from the patients peritoneal dialysis nurse which showed the patient was admitted on (b)(6) 2015 for sepsis related to alpha-hemolytic streptococcal peritonitis associated with peritoneal dialysis.The patient was treated with intraperitoneal vancomycin.He was also treated for hyponatremia.The patient was discharged on (b)(6) 2015.

Manufacturer Narrative

Medical record review: on (b)(6) 2015 the patient presented to the hospital with nausea, vomiting, and abdominal pain.On (b)(6) 2015, pd effluent was collected and cultured, the patient was diagnosed with peritonitis, and was initiated on a broad-spectrum empiric antibiotic therapy; drug name, dose, route, and frequency unknown.On an unknown date during the admission, the pd culture results revealed alpha-hemolytic streptococcus.On an unknown date during the admission, the patient started vancomycin every three to four times per week depending on vancomycin through levels for three weeks, with dose and route unknown.As (b)(6) 2015, the patient was discharged from the hospital and the episode of peritonitis was resolving.There is no documentation in the medical record supporting a possible association between the liberty cycler, delflex peritoneal dialysis solution, and the event of peritonitis.The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5346746
• MDR Text Key: 35215206
• Report Number: 2937457-2015-01772
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2012
• 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
• Patient Age: 45 YR
• Patient Weight: 110