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

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 06/16/2014

Event Type  Injury  

Event Description

The following is based on new medical record received from the patient's treatment facility.During review of medical records it was discovered that the patient had an episode of culture-negative peritonitis in (b)(6) 2014 that was effectively treated.The patient was sent from the dialysis clinic to the er to be evaluated for peritonitis.He presented at the er with complaints of cloudy peritoneal fluid.The patient had abdominal pain the previous few days which he described as crampy.The patient was administered intravenous tobramycin and vancomycin for suspected peritonitis.The patient was treated with intraperitoneal vancomycin and tobramycin to continue on an outpatient basis and was discharged from the er.On (b)(6) 2014, the patient's treatment was switched to intraperitoneal ancef, oral cipro and prednisone due to redman's reaction to the vancomycin.Patient was diagnosed with culture negative peritonitis which was eventually resolved.

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.Based on the 25 pages of medical records information, it appears the patient was sent to the emergency room on (b)(6) 2014 and diagnosed with culture-negative peritonitis.The patient was treated in the er with intravenous antibiotics and discharged.The patient's antibiotics were changed due to patient's redman reaction to the vancomycin.Peritonitis is a known complication of peritoneal dialysis, caused by poor aseptic technique or a break in the sterile field.There is no documentation in the medical record that indicates a causal relationship between the liberty cycler, the liberty cycler connector or the solutions and the diagnosis of culture negative peritonitis.A supplemental report will be submitted upon completion of the plant's investigation.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CM
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4768339
• MDR Text Key: 15893197
• Report Number: 2937457-2015-00873
• 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: Other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• 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: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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: PRAVASTATIN; VITAMIN D,; VISION FORMULA,; PD SOLUTION,; ONGLYZA,; HYDRAZINE,; PROPRANOLOL,; LORATADINE; PRANDIN,; CILOSTAZOL,; ASPIRIN,; LASIX,; LIBERTY CYCLER SET,; SODIUM BICARBONATE,; CARBIDOPA-LEVODIPA,; MELATONIN,; WARFARIN,; FOLIC ACID,; CLONIDINE,; NORVASC,; ZYLOPRIM,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 92