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 Incontinence (1928); Seizures (2063); Dizziness (2194); Loss of consciousness (2418)

Event Date 01/07/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, the pt began seizing and became non responsive 7 minutes into her dialysis treatment.The pt's blood was returned and the pt was transported to the hosp via ambulance.The pt had an episode of urinary incontinence following this episode.The pt stated she "remembers feeling dizziness / lightheadedness 15 minutes into hemodialysis." pt received neurologic and cardiac workups while hospitalized.The remainder of the pt's hospitalization was uneventful and the pt was discharged on (b)(6) 2013.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 1025 pages of med records info it appears that on (b)(6) 2013, the pt began seizing and became non responsive 7 minutes into her dialysis treatment.The blood was returned, 911 notified and pt was transported to hosp.The pt had an episode of urinary incontinence following this episode.Pt was treated for cardiac issues in the hosp.Seizure was ruled out.There is no documentation in the med record that shows a causal relationship between the pt's dialysis treatment or dialysis products and the pt's episode of responsiveness.It should be noted that this pt had missed her dialysis treatment on (b)(6) 2013.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: 4548516
• MDR Text Key: 5527033
• Report Number: 8030665-2015-00090
• 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: NATURALYTE; FRESENIUS 2008K; FRESENIUS COMBISET BLOODLINES; FMC DIALYZER; SALINE; GRANUFLO
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 66