MAUDE Adverse Event Report: UNKNOWN; 3M 1)SINGLE NEEDLE ( CO-AXIAL FLOW) DIALYSIS KIT; SINGLE NEEDLE (CO-AXIAL FLOW) DIALYSIS KIT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Vomiting (2144); Loss of consciousness (2418)

Event Type  Injury  

Event Description

A peritoneal dialysis nurse reported that 3 3/4 hours in to a scheduled 4 hour hemodialysis treatment, machine was alarming and patient was found vomiting and unconscious, b/p 57 /37; pulse 65.When staff attempted to administer normal saline it was found that both arterial and venous needles were dislodged due to the 3m tape.Ebt.On floor 200ml.Patient was re-cannulated with a new fistula needle and a total of 400ml normal saline was administered; oxygen was applied and ems was called, patient was transported to hospital where the patient later.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 1)SINGLE NEEDLE ( CO-AXIAL FLOW) DIALYSIS KIT
• Type of Device: SINGLE NEEDLE (CO-AXIAL FLOW) DIALYSIS KIT
• Manufacturer (Section D): UNKNOWN; 3M
• MDR Report Key: 17526031
• MDR Text Key: 321075240
• Report Number: MW5132971
• Device Sequence Number: 1
• Product Code: PPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: KGX MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE