MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER SET DUAL CONNECT

Catalog Number 050-87212

Device Problem Insufficient Information (3190)

Patient Problem Angina (1710)

Event Date 08/13/2014

Event Type  Injury  

Event Description

It was reported that the patient was on the cycler when he felt chest pains.The patient's physician has determined that the patient had a heart attack (mi) that actually occurred two days before (b)(6), the patient was advised by his physician that he was just experiencing residual symptoms.Reportedly the patient initially experienced discomfort on (b)(6), when the mi apparently occurred, but he was not on the cycler at the time.The patient also reported he did not feel well on (b)(6).He went to the er on (b)(6) 2013, and was admitted.He had two coronary stents placed and was released on (b)(6).Medical records have been requested.

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.A supplemental report will be submitted upon final review of medical records by post market clinical and completion of the plant's investigation.This report is related to two other product reports submitted on the same event.

• Brand Name: LIBERTY CYCLER SET DUAL CONNECT
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; reynosa, tamaulipas CP88 780; MX CP88780
• Manufacturer Contact: corie vazquez, manager ; 920 witner st.; waltham, MA 02451-1457 ; 7816999017
• MDR Report Key: 4112569
• MDR Text Key: 4839523
• Report Number: 8030665-2014-00730
• 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: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DEFLEX SOLUTION; LIBERTY CYCLER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 84