MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); No Code Available (3191)

Event Date 03/26/2013

Event Type  Death  

Manufacturer Narrative

(b)(4).Additional information has been requested and will be submitted upon receipt accordingly.The initial medwatch 3500a for this reportable event was timely submitted on (b)(6) 2016 (reference submission core id (b)(4)).The regulatory body date timestamp for acknowledgement 2 was (b)(6) 2016, 19:22:16.Acknowledgement 2 received a status of passed.The regulatory body date timestamp for acknowledgement 3 was fri (b)(6) 19:23:36 edt 2016.Acknowledgement 3 received a status of failed due to ¿input date can not be greater than today.:report identifier:(b)(6) 2016:¿ further inquiry to the fda submission support team at cesub help desk (b)(6) noted that acknowledgement 3 failed due to a difference in time zone.The cesub help desk requested that the medwatch be resubmitted and noted it should pass the validation process.Note: this report will not be reflected as a late mdr on the manufacturer¿s behalf as times zones should not be a concern for timely reporting under mdr.This is one of two reports associated with this event, manufacturer report numbers 1225714-2016-00133 and 1225714-2016-00134.

Event Description

The plaintiff's attorney alleged the patient attended a routine dialysis appointment and thereafter experienced a sudden cardiopulmonary event.The patient was transferred to the hospital and expired approximately three weeks later.Further information noted prior to the patient's demise, on four separate occasions, the patient had experienced adverse reactions and was hospitalized on each occasion.

• Brand Name: NATURALYTE
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 920 winter street; waltham MA 02451
• Manufacturer (Section G): CORPORATE; 920 winter street; waltham MA 02451
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5961314
• MDR Text Key: 55096531
• Report Number: 1225714-2016-00134
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening