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

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

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)

Event Date 10/06/2015

Event Type  Injury  

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.This is one event (cardiovascular) of two events reported for the same patient involving two separate incidents.A supplemental report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis patient presented to inpatient dialysis with a pre-existing history of cardiac issues and experienced cardiac arrest.While in treatment the patient coded and his internal defibrillator fired unsuccessfully.A crash cart was deployed and the hospital defibrillator was successful in restoring the patient's cardiac rhythm.The patient was defibrillated due to a previous heart condition.The patient had been placed on dnr.The patient had a 10% ejection fraction rate and ongoing heart issues.The patient experienced multiple acute mi's (myocardial infarction) during the hospitalization.On (b)(6) 2015 the patient expired during treatment on another cycler.The pdrn stated the doctor did not believe the cycler caused the patient's hospitalization or subsequent death.

Manufacturer Narrative

Device review: external, visual inspection: a visual inspection of the returned cycler exterior showed no sign of physical damage.The heater tray/scale was not obstructed.The simulated treatment was performed and completely without the failures.The valve actuation test passed.The system air leak test passed.The load cell value and verification was within tolerance.The patient sensor calibration check passed.The teach pumps test passed.The voltage check passed.There were no discrepancies encountered in the internal inspection of the cycler.There were no deviations or nonconformances during the manufacturing process.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The system level review of cycler device and concomitant products found no indication that the products caused or contributed in any way to the clinical event.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS USA, INC.; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5213407
• MDR Text Key: 31013538
• Report Number: 2937457-2015-01580
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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): Hospitalization; Required Intervention