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

Catalog Number RTLR180111

Device Problem Invalid Sensing (2293)

Patient Problem Peritonitis (2252)

Event Date 01/08/2015

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) nurse reported a patient was diagnosed with peritonitis.The nurse reported the patient was nauseated and vomited prior to using the cycler but attempted pd on the cycler.The patient was unable to complete dialysis and his spouse took the patient to the hospital on an unknown date.It is unknown whether or not the patient was admitted, or for what length of time.The pd nurse reported the patient's infection had nothing to do with the cycler.As of (b)(6) 2015, the patient continues to use continuous cycler-assisted peritoneal dialysis (ccpd) therapy without any further issues.No further information was shared regarding this patient.

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 information provided, it is unknown how the device may have caused or contributed to the event.The plant investigation is in progress and a supplemental medwatch will be submitted upon completion.

• 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 cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4530769
• MDR Text Key: 16853766
• Report Number: 2937457-2015-00166
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2009
• 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 CYCLER CASSETTE; DELFLEX PD SOLUTION
• Patient Outcome(s): Required Intervention