MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET BLOODLINES

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/21/2014

Event Type  Injury  

Event Description

It was reported by user facility that pt's blood pressure dropped and he lost consciousness.Pt was sent to the emergency room and eventually sent home.Customer stated air from the saline bag went through level detector with no alarm.

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 info provided, it is unk how the device may have caused or contributed to the event.The post market clinical department is in the process of requesting add'l relevant pt medical records and treatment data regarding the reported event and a plant investigation is underway.A supplemental report will be submitted upon completion of the clinical staff's assessment of the reported info and the plant's investigation.

• Brand Name: FRESENIUS COMBISET BLOODLINES
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque idnustrial; MX
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4364434
• MDR Text Key: 18541833
• Report Number: 8030665-2014-00923
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• 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: NATURALYTE LIQUID BOCARBONATE; FRESENIUS 2008 T HEMODIALYSIS SYSTEM; FMC DIALYZERS
• Patient Outcome(s): Life Threatening