MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008

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

Patient Problem Pulmonary Infarction (2021)

Event Date 11/13/2014

Event Type  Injury  

Event Description

The user facility reported that a pt had been on hemodialysis for approximately four mins and started to complain of chest pain.Dialysis was discontinued and pt was transported to the hosp.The 7000 units of heparin was given at the beginning of treatment.During f/u with user facility on (b)(6) 2014, it was reported that pt had a pulmonary embolism and was still in the hosp.

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 drug may have caused or contributed to the event.The post market clinical dept 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 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4340049
• MDR Text Key: 16994569
• Report Number: 8030665-2014-00911
• 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
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• 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: 11/13/2014
• 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: OPTIFLUX DIALYZER; SALINE; NATURALYTE PRODUCTS; FRESENIUS 2008K2 HEMODIALYSIS SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention