MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS 2008T HEMODIALYSIS SYSTEM

Catalog Number 03-2794-0

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

Patient Problems Syncope (1610); Tachycardia (2095)

Event Date 10/01/2014

Event Type  Injury  

Event Description

The user facility reported that about 1 hour 45 minutes into treatment, patient's uf was turned down and they had him stand up due to restless leg syndrome.About 20 minutes later, patient was unresponsive with no pulse.Patient was revived and sent to icu.The patient was wearing a holter monitor that had been placed on (b)(6) 2014.He was admitted and monitored closely in icu.After review of all ekgs, holters, rhythm strips surrounding recent events, patient felt to have sinus tachycardia.No arrhythmias were noted.No av nodal blocks or atrial fibrillation.Echo was essentially normal.Patient was given potassium due to low of 3.4 after dialysis, however, required kayxelate due to high potassium of 5.5.He had no further episode of dizziness, syncope, chest pain and no arrhythmias on monitor.He was discharged on (b)(6) 2014 to home to follow up with dialysis session as scheduled.

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 reviewing 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: FRESENIUS 2008T HEMODIALYSIS SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4223635
• MDR Text Key: 5002788
• Report Number: 8030665-2014-00844
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• 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: 10/01/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: NATURALYTE; DIALYZER; 2008T HEMODIALYSIS SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR