MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET, DUAL PATIENT CONNECT

Catalog Number 050-87212

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: the device was not returned to the manufacturer for physical evaluation.The customer was unable to provide the manufacturer with the lot number of the product used in the reported event.As no lot number was provided by the complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event.The record review found 2 lot number shipped to the customer during that time period.The batch production records for these lots were reviewed.The batch records confirmed that released product met specifications; and documented manufacturing process controls were within specification.Per the documented product investigation, there was no indication that the fresenius product caused, contributed to or was a factor in the reported event.The paper mdr submission (mfr report # 8030665-2015-00505) follow-up # 001 was submitted on 11/feb/2016 to the office of center for devices and radiological health and returned to fresenius medical care with a cover letter dated 17/feb/2016 stating the paper mdr submission was not accepted.Therefore, the report was resubmitted electronically via webtrader.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynos; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 900 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5213411
• MDR Text Key: 31023237
• Report Number: 8030665-2015-00505
• 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
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention