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

Device Problem Occlusion Within Device (1423)

Patient Problem Dyspnea (1816)

Event Date 12/30/2013

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) nurse called to replace her patient's cycler due to the patient experiencing shortness of breath (sob) during treatments on (b)(6) 2013.Per the pdrn the patient's daughter was concerned about the patient not draining enough.The pdrn thought it could have been catheter related, so placement was checked.Catheter placement was noted to be good.Upon further investigation the pdrn believed the daughter was not letting the machine run long enough to drain.The registered nurse educated the daughter.The registered nurse stated that the pt was experiencing shortness of breath due to his chronic congestive heart failure (chr).The nurse also reported the patient's shortness of breath related to congestive heart failure resulted in two hospitalizations on (b)(6) 2014 and again on week of (b)(6) 2014.The patient's congestive heart failure is an ongoing issue.

Manufacturer Narrative

Add'l attempts to the patient have been made with no add'l info provided.This mdr includes all event info received to date.Due to the lack of add'l info and the allegation of shortness of breath that required hospitalization this mdr is being filed as a serious injury.A follow-up mdr will be submitted after a clinical review by the medical direction, and plant investigation is completed.Associated complaints: 2937457-2014-00128, 2937457-2014-00129 and 2937457-2014-00130.

• 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 ; 920 winter street; waltham, MA 02451 ; 7816999000
• MDR Report Key: 3624766
• MDR Text Key: 16803194
• Report Number: 2937457-2014-00130
• 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
• Type of Report: Initial
• Report Date: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• 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
• Date Manufacturer Received: 12/30/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2013
• 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: LIBERTY TUBING, PD SOLUTION
• Patient Outcome(s): Hospitalization