MAUDE Adverse Event Report: NXSTAGE MEDICAL INC. MEDISYSTEMS TWIN PACK HEMODIALYSIS FISTULA NEEDLE SET 16G; NEEDLES

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 07/26/2017

Event Type  Death  

Event Description

On (b)(6) 2017, (b)(6) rn, home hemodialysis nurse went to pt's home to help with cannulation.Upon cannulating, the nurse realized the blue clamp needle was in the arterial limb of the graft and the red clamp needle was in the venous limb of the graft.The pt refused re-cannulation.The nurse attached the red pt line to the blue needle (arterial side of graft), and the blue pt line to the red needle (venous side of graft).(b)(6) rn, home hemodialysis nurse stated she instructed pt on take-off procedure, labeled the needles for easy identification on take off.Pt verbalized understanding of which line she will utilize to return her blood.At the end of the hemodialysis treatment, the pt was found unresponsive by her mother, who has her care partner.The pt's mother reports that there was a large amount of blood on the floor.The pt's mother immediately shut off the cycler and called 911.Police and ems arrived at the home and transported the pt to (b)(6) hospital via ambulance.Dr.(b)(6) notified (b)(6) rn, home hemodialysis nurse at approx 3:15pm that the pt had expired.

• Brand Name: MEDISYSTEMS TWIN PACK HEMODIALYSIS FISTULA NEEDLE SET 16G
• Type of Device: NEEDLES
• Manufacturer (Section D): NXSTAGE MEDICAL INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 6914000
• MDR Text Key: 88246155
• Report Number: 6914000
• Device Sequence Number: 3
• Product Code: FIE
• Combination Product (y/n): N
• 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: 08/25/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2017
• Distributor Facility Aware Date: 07/26/2017
• Event Location: Home
• Date Report to Manufacturer: 08/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 36