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 Low Blood Pressure/ Hypotension (1914); Seizures (2063); Vomiting (2144)

Event Date 01/23/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, the pt had 20 minutes remaining in her dialysis treatment when she complained of not feeling well.Her blood pressure dropped from 170s to 137/89 and the pt proceeded to vomit and have seizure like activities.Oxygen was administered at 2 liters/minute via nasal cannula.Her blood was returned and ems was called.The pt continued to have additional seizure activity and vomiting prior to arrival of the ambulance.The pt refused to go to the hosp.She was alert and oriented x3.The pt was encouraged to go to the er if she started feeling worse.Pt was discharged stable, ambulatory, gait steady.On (b)(6) 2013, dialysis composition: 2.0 k, 2.25 ca, 0.75 mg, 100 dextrose.Sodium (meq/l): 40.Blood volume processed = 81.Bfr = 450.Scheduled time = 3.0.

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 1925 pages of med records info, it appears that on (b)(6) 2013 the pt's blood pressure dropped and she became unresponsive during her dialysis treatment.Pt recovered but refused to resume dialysis treatment or go to the hosp.There is no documentation in the med record that shows a causal relationship between the pt's unresponsive episode and the pt's hemodialysis treatment and dialysis 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): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: corie vazquez ; 920 winter st; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4548515
• MDR Text Key: 5522148
• Report Number: 8030665-2015-00091
• 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 2008K; FRESENIUS COMBISET BLOODLINES; NATURALYTE; SALINE; VENOFER
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 66