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

Model Number 03-2795-7

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

Patient Problem Cardiac Arrest (1762)

Event Date 03/24/2014

Event Type  Injury  

Event Description

It was reported by a user facility a patient experienced a cardiac arrest during treatment.Prior to the event; it was reported the patient was not feeling well and lost consciousness.The patient showed no response from the administration of normal saline bolus.The patient had no pulse and cpr was initiated.Emergency medical service was called, the patient was connected to a defibrillator, a heart rhythm was detected and no shock was administered.The patient was then transported to the hospital for treatment.

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 physician and completion of the plant's investigation.Related mdr 1225714-2014-01573, 1225714-2014-01574, 8030665-2014-00315, 2937457-2014-00642 and 1713747-2014-00207.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque industrial reynosa; reynosa, tamaulipas 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3875157
• MDR Text Key: 16803422
• Report Number: 8030665-2014-00315
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03-2795-7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/23/2014
• 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: GRANUFLO; 2008K HEMODIALYSIS MACHINE; FRESENIUS DIALYZER; 0.9% SALINE SOLUTION; NATURALYTE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 92