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

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

Patient Problems Death (1802); Loss of consciousness (2418); Shaking/Tremors (2515); No Code Available (3191)

Event Date 10/14/2013

Event Type  Death  

Event Description

On (b)(6) 2013, the patient attended hemodialysis treatment.Within 5 minutes of treatment, the patient stated "i'm getting that feeling again".Patient became unresponsive, with arms jerking and agonal breathing".O2 was applied and the patient was placed in a trendelenberg position.The 911 was called and the patient was sent to the emergency room via ambulance.The patient was sent back from the emergency room to the dialysis unit.At approximately 12:30 the patient became unresponsive, again.The aed (automated external defibrillator) was applied and no shock was advised.The patient was sent back to the emergency room via ambulance.Medical record shows that the patient was discharged to the hospital and expired approximately 2:30 pm.

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 1925 pages of medical records information it appears that on (b)(6)2013, this patient had an unresponsive episode during dialysis.She was then sent back to the emergency room after another episode and subsequently expired.There is no documentation in the medical record that shows a causal relationship between the patient's dialysis and dialysis products and the patient's death.A supplemental report will be submitted upon completion of 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 industrial reynosa; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: corie vazquez ; 920 winter st.; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4548314
• MDR Text Key: 5522061
• Report Number: 8030665-2015-00094
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• 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?: No
• Date Manufacturer Received: 01/30/2015
• 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: GRANUFLO; FMC DIALYZER; FRESENIUS COMBISET BLOODLINES; SALINE; NATURALYTE; FRESENIUS 2008K
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 66