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

Device Problem Device Handling Problem (3265)

Patient Problem Colostomy (2552)

Event Date 01/29/2015

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) pt reported being in the hospital with an infection.A follow up call was made to the peritoneal dialysis clinic.The pt was admitted to the hosp on (b)(6) 2015 with peritonitis due to a break in sterile technique.The pt was discharged home from the hosp on (b)(6) 2015.The following is from the med records provided by the patient's treatment facility.The pt presented with hypertension and a one to two day history of abdominal pain, nausea and diminished appetite.He was treated with zosyn and vancomycin and then levofloxin and vancomycin.He received pd therapy during his admission.Lisonopril was added to treat his continued hypertension.

Manufacturer Narrative

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

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 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 ; 7816999000
• MDR Report Key: 4585030
• MDR Text Key: 5453020
• Report Number: 2937457-2015-00311
• 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,User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 55