MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING LIBERTY DIALYSIS CATHETER

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

Patient Problems Abdominal Pain (1685); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Chills (2191); Peritonitis (2252)

Event Date 06/07/2014

Event Type  Injury  

Event Description

A peritoneal dialysis nurse reported that patient has been in the hospital since (b)(6) 2014.Nurse stated that she does not think it is pd related and that patient's blood cultures were positive, was septic and patient's pd cultures were negative, no peritonitis.On (b)(6) 2014, the patient was seen in the emergency room (er) with a chief complaint of abdominal pain.She was transferred to the intensive care unit with diagnoses of: sepsis, peritonitis, leukocytosis and hypotension secondary to septic shock, and electrolyte abnormalities.The patient started peritoneal dialysis (pd) with the "past few months" and also had her pd catheter placed.She has been deteriorating since then with failure to thrive.She was started on intravenous (iv) antibiotics.Her systolic blood pressure ranged between 30 and 60.She was started on a levophed drip for blood pressure maintenance.She was positive for abdominal pain, chills, generalized weakness and fatigue.Blood culture results from (b)(6) 2014 were (b)(6).The patient's effluent pd fluid culture results showed wbc's; moderate, epithelial cells: rare, no organism present; which along with her complaint of abdominal pain was positive for a diagnosis of peritonitis.In the icu, the patient was started on iv vancomycin and ceftazidime.On (b)(6) 2014, the patient was feeling better, but still required iv antibiotics and iv clinimix for nutrition.She was discharged to an assisted care facility.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device history record review confirmed labeling, material, and process controls were within specification.The post market clinical staff reviewed the provided medical records.Based on the medical records information, it appears that on (b)(6) 2014, the patient was seen in the er with a chief complaint of abdominal pain.She was transferred to the intensive care unit with diagnoses of: sepsis, peritonitis, leukocytosis and hypotension secondary to septic shock and electrolyte abnormalities.The diagnoses of septic shock with hypotension, pneumonia, leukocytosis, and electrolyte abnormalities are not related to the use of the liberty cycler.It was documented that the patient was in a state of failure to thrive, which would contribute to those events.The event of peritonitis was diagnosed due to the patient having abdominal pain and wbc's in her effluent pd fluid.There were no organism seen in her pd fluid.Peritonitis is a known complication of pd and is usually the result of a breach in aseptic technique during pd.

• Brand Name: LIBERTY DIALYSIS CATHETER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4016949
• MDR Text Key: 17696294
• Report Number: 2937457-2014-01789
• 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: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: LIBERTY DIALYSIS TUBING; PD SOLUTIONS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR