MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET ACCESS FLOW REVERSE CON TWISTER

Catalog Number 03-2794-0

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

Patient Problems Syncope (1610); Vaso-Vagal Response (2661)

Event Date 10/17/2014

Event Type  Injury  

Event Description

The user facility reported that patient coded on machine approximately mid to end of treatment.The patient complained of stomach cramps and then the patient's eye rolled back.He was ambu-bagged and sent to icu and discharged the next day.This is the third event of this nature.(syncope/vasovagal): (b)(6) 2014.

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 post market clinical department is in the process of obtaining updated patient medical records and a plant investigation is underway.A supplemental report will be submitted upon completion of the clinical staff's assessment of the reported information and the plant's investigation.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas, cp 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4265545
• MDR Text Key: 17694119
• Report Number: 8030665-2014-00864
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2794-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONCENTRATES; OPTIFLUX DIALYZER; 2008T HEMODIALYSIS SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR