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

Catalog Number 03-2722-9

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

Patient Problems Bacterial Infection (1735); Low Blood Pressure/ Hypotension (1914)

Event Date 03/02/2015

Event Type  Injury  

Event Description

During review of medical records for this patient for a separate event, it was discovered that patient became hypotensive and started feeling poorly during hemodialysis on (b)(6) 2015.It was suspected that patient's vancomycin resistant enterococcus (vre) infection had started again and he was started on zosyn and zyvox.An infectious disease consult was ordered.Blood culture on (b)(6) 2015 confirmed that patient had vre in his bloodstream.The patient was changed to daptomycin.

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.Medical record review: medical records were received and reviewed by post market surveillance clinical staff.It was noted the patient had been admitted into the hospital on (b)(6) 2015 to rule out pulmonary embolism.The contrast dye caused contrast-induced nephropathy that led to renal failure and eventually hemodialysis.During his hospitalization, the patient also developed vre sepsis.The patient's vre never resolved and the patient started having episodes of hypotension during hemodialysis on (b)(6) 2015.During this episode, the patient was unable to complete treatment due to his inability to maintain a systolic blood pressure of 90 even with the administration of dopamine drip.There are no bicarbonate levels in the medical record for review.The medical records do not show a causal relationship between the 2008k or the concomitant products used in the patient's hemodialysis treatment and the patient's hypotension.Medical records do show that the patient's unresolved infection was a possible contributor to the hypotensive episodes during his hemodialysis treatment.A supplemental report will be submitted upon completion of 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, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4764610
• MDR Text Key: 17630792
• Report Number: 8030665-2015-00234
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2015
• 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: NATURALYTE BICARBONATE; NATURALYTE; 2008K HEMODIALYSIS SYSTEM; OPTIFLUX DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 59