inforMED
InjuryFOZ

AV FISTULA NEEDLE

Received Feb 25, 2005 · Event occurred Feb 11, 2005

Report 579068 · MDR key 579068

Device

Generic name

Dialysis Fistula Needle

Model number

UNK

Catalog number

UNK

Lot number

041014253

Product problems

  • Device Alarm System
  • Leak/Splash
  • Material Separation

Patient

77 YR

  • Therapy/non-surgical treatment, additional
  • Hospitalization required
  • Blood Loss

Narrative

Description of Event or Problem

A PATIENT WAS UNDERGOING DIALYSIS. THE VENOUS NEEDLE SLIPPED OUT OF THE ACCESS. THE NEEDLE WAS ATTACHED BY TAPE TO THE OUTSIDE OF THE ACCESS. A PIECE OF TAPE WAS OCCLUDING THE NEEDLE; THEREFORE THE ALARM DID NOT GO OFF. THE PATIENT WAS ADMINISTERED O2 AND GIVEN 1500CC NS. BLOOD TRANSFERRED WAS RETURNED TO THE PATIENT AFTER TREATMENT. THE PATIENT WAS SENT VIA AMBULANCE TO A LOCAL HOSPITAL AND ADMITTED FOR A CARDIAC WORK UP. THE PATIENT WAS ALERT, B/P STABLE, AND RESPONSIVE WHEN TRANSFERRED BY AMBULANCE TO THE HOSPITAL.