MAUDE Adverse Event Report: FRESENIUS; 2008 T

Device Problems Device Alarm System (1012); Failure to Sense (1559)

Patient Problems Cardiac Arrest (1762); Exsanguination (1841)

Event Date 06/16/2014

Event Type  Injury  

Event Description

Venous needle dislodgement with estimated 500cc blood loss.Machine did not alarm nor did blood pump stop.Patient found unconscious.Nurse turned off blood pump and clamped lines.Cpr started.911 called.Three liters of ns given.Patient transported to emergency room per ambulance.Machine verified in service mode to be at asymmetric 100.

• Brand Name: FRESENIUS
• Type of Device: 2008 T
• MDR Report Key: 4051847
• MDR Text Key: 4731253
• Report Number: 4051847
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BENEHOLD MEDICAL TAPE STRIPS; SETS; MEDISYSTEMS TWIN PACK HEMODIALYSIS FISTULA NEEDLE
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 102