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

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

Patient Problems Macular Edema (1822); Fever (1858); Tachycardia (2095)

Event Date 10/05/2011

Event Type  Injury  

Event Description

On (b)(6) 2011, this pt presented at the emergency room with tachycardia.The pt experienced tachycardia that morning at the beginning of her dialysis which persisted.The pt was able to complete treatment.Patient's temperature was 100.1 with a pulse rate of 134.The pt had mild to moderate facial and arm edema.The etiology of the patient's leukocytosis was not known.

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) 2011, this pt presented at the emergency room with tachycardia.The pt experienced tachycardia that morning at the beginning of her dialysis which persisted.The pt was able to complete treatment.Medical records reveal that the pt was non-compliant with medication regimen - especially her phosphate binder, her diet and her dialysis treatments.Medical records also revealed that the pt had chronic tachycardia and hypertension.There is no documentation in the medical record that shows any casual relationship between the patient's dialysis treatment and products during the treatment to the patient's hospitalization for tachycardia.A supplemental report will be submitted upon completion of the plant's investigation.

• Brand Name: FRESENIUS COMBISET BLOODLINES
• Manufacturer (Section D): FRESENIUS MED CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: corie vazquez ; 920 winter st; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4538956
• MDR Text Key: 5514248
• Report Number: 8030665-2015-00085
• 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: 02/23/2015
• 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; FRESENIUS COMBISET BLOODLINES; FRESENIUS 2008K; FMC DIALYZER; SALINE; NATURALYTE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 66