MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LOW VOLUME PRE-PUMP BLOODLINE (12/CS)

Catalog Number 03-2692-6

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

Patient Problem Death (1802)

Event Date 12/04/2013

Event Type  Death  

Event Description

It was reported that a hemo-dialysis patient on (b)(6) 2013 passed away one half hour after completing treatment.The patient was disconnected from machine.Upon f/u with the clinical manager of the facility, it was determined that the patient was in icu during the time of treatment.The patient displayed signs of cardiac symptoms.She stated that the patient passed away due to internal bleeding.The patient's death was unrelated to the k-machine.The machine completed a series of test and was found to be working as specified.The machine was placed back on the floor for daily use.

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 information provided, no definitive conclusion can be drawn.The post market clinical staff is currently in the process of requesting patient medical records including a death certificate and autopsy report.A supplemental report will be submitted upon final review of medical records by post market clinical physician and completion of the plant's investigation.

• Brand Name: LOW VOLUME PRE-PUMP BLOODLINE (12/CS)
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal #326; reynosa, tamps, cp 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3640914
• MDR Text Key: 4285529
• Report Number: 8030665-2014-00154
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2692-6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• 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: Initial
• Patient Sequence Number: 1
• Treatment: 2008K; UNK FRESENIUS DIALYZER; NATURALYTE
• Patient Outcome(s): Death