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 Fever (1858); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Chills (2191)

Event Date 06/13/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, this pt was sent to the emergency room following her dialysis treatment and subsequently admitted with a fever of 102f, shaking chills and hypertension.The pt received intravenous antibiotics for bacteremia.The pt was discharged (b)(6) 2012.

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 (b)(6) pages of medical records information, it appears that on (b)(6) 2012, this pt was admitted into the hosp for bacteremia.The pt had blood cultures (b)(6) for (b)(6).There is no documentation in the medical record concerning the etiology of the bacteremia.In addition, there is no documentation in the medical record that shows a casual relationship between the patient's bacteremia and the patient's dialysis treatment and dialysis treatment components/products.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: 4538928
• MDR Text Key: 22031197
• Report Number: 8030665-2015-00086
• 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: FMC DIALYZER; SALINE; NATURALYTE; FRESENIUS COMBISET BLOODLINES; GRANUFLO; FRESENIUS 2008K
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 66