MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS HEMODIALYSIS MACHINE

Model Number 2008L

Device Problems Couple, failure to (1134); Emergency stop button or switch failure (1206); Alarm system, failure of check-catheter (1620)

Patient Problems Asystole (1727); Bleeding (1738)

Event Date 12/01/2013

Event Type  Death  

Event Description

Dialysis line found to be disconnected, air seen in the arterial line.No alarms sounded.Pt arrested and could not be resuscitated.Reference mfr number: 2937457-2014-00008.

• Brand Name: FRESENIUS HEMODIALYSIS MACHINE
• Type of Device: DIALYSIS MACHINE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 920 winter street; waltham MA 02451 145
• MDR Report Key: 3606189
• MDR Text Key: 4171742
• Report Number: 3606189
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2014,12/03/2013
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2008L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2013
• Distributor Facility Aware Date: 12/01/2013
• Device Age: 6 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR