MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS 2008K/K2 TWISTER REVERSE FOW DEVICE

Catalog Number 03-2794-0

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

Patient Problems Syncope (1610); High Blood Pressure/ Hypertension (1908)

Event Date 08/08/2014

Event Type  Injury  

Event Description

It was reported by the user facility that a patient coded during hemodialysis treatment.The treatment record provided by the user facility states patient had pain in left leg due to restless leg syndrome.Patient was given tylenol 650 mg and ice pack was applied to this left leg followed by warm pack.Soon after, he became non-responsive with agonal type breathing.Blood pressure was 216/141.Patient was sternal rubbed with no response.One liter of normal saline was given and micu/sicu nurses and dialysis nurse called code.Patient was ambu bagged with 100% oxygen immediately.Code team responded quickly and patient was moved from the dialysis chair to the floor, and then to a bed.Patient vomited several times after moving to the bed, suction was ready and the head of the bed was lifted.Stat labs were drawn.Patient began responding verbally, making eye contact, and breathing on his own effectively with no rebreather mask in place.Patient was transferred to micu/ccu.

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 2008K/K2 TWISTER REVERSE FOW DEVICE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; cd, reynosa, tamaulipas ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4185780
• MDR Text Key: 5095410
• Report Number: 8030665-2014-00805
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• 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?: No
• Date Manufacturer Received: 09/19/2014
• 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; 2008K2 HEMODIALYSIS SYSTEM; OPTIFLUX 180RNRE DIALYZER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR