MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.A supplemental report will be upon completion of the plant¿s investigation.

Event Description

A peritoneal dialysis patient's nurse reported a patient developed culture negative peritonitis.The patient was treated with vancomycin and ciprofloxacin.The nurse also reported that as of (b)(6) 2016, the patient's signs and symptoms of peritonitis have resolved, and she continued to use continuous cycler-assisted peritoneal dialysis (ccpd) therapy without further issue.

Manufacturer Narrative

Clinical review of the medical records did not reveal the cause of peritonitis.There was no documented diagnosis of peritonitis however; ispd guidelines/recommendations for peritoneal dialysis related infections reveal that effluent cell count with white blood cells (wbc) more than 100/ml, with at least 50% polymorphonuclear neutrophil cells, indicates the presence of inflammation with peritonitis being the most likely cause.There was no documentation in the medical record that indicates there was any causal relationship between the liberty cycler and the patient¿s 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.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The system level review of the liberty cycler and concomitant products found no indication that the products caused or contributed in any way to the clinical event.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5695545
• MDR Text Key: 46437953
• Report Number: 2937457-2016-00570
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

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: 05/13/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• 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): Required Intervention
• Patient Age: 73 YR