inforMED
InjuryFJT

MAHURKAR

Received Mar 22, 2010 · Event occurred Jan 26, 2010

Report 1651892 · MDR key 1651892

Device

Generic name

Catheter Dual Lumen,curved Extensions,laser-cut Side Slots

Model number

8830415003

Catalog number

8830415003

Lot number

*

Product problems

  • Loose or Intermittent Connection

Patient

28 YR

  • Air Embolism
  • Loss of consciousness

Narrative

Description of Event or Problem

THE PATIENT HAD A NEW APHERESIS CATHETER PLACED IN INTERVENTIONAL RADIOLOGY. SHE RETURNED TO HER ROOM. THE APHERESIS WAS SET UP AND INITIATED. THE PATIENT BECAME UNRESPONSIVE WITHIN 18 MINUTES AND PRESENTED WITH SYMPTOMS OF A STROKE. A HEAD CT SCAN SHOWED AN AIR EMBOLISM. THE PATIENT HAD A PATENT FORAMEN OVALE (PFO). THE EXACT CAUSE OF THE EMBOLISM IS UNKNOWN AND EXPECTED TO BE HUMAN ERROR. UPON REVIEW OF THE CASE, WE DID NOTE THAT THE CATHETER USED DID NOT HAVE A CONNECTION THAT WOULD ALLOW FOR THE STANDARD PHERESIS TUBING OR NEEDLESS ADAPTOR TO SCREW COMPLETELY ONTO THE HUB. THERE IS A 1/4 TURN ON THE CONNECTION, NOT A FULL TURN SEEN WITH MOST OTHER CATHETER CONNECTIONS. THE EXPOSED GROOVES COULD POTENTIALLY ACT AS A SOURCE FOR INFECTION. SIMULATION OF THE CONNECTION WITH THE PRESSURE OF APHERESIS DID DEMONSTRATE A TIGHT SEAL. HOWEVER, THE CONNECTION CAN COME UNDONE EASILY IF NOT TIGHT ENOUGH. IT CAN ALSO BE DIFFICULT TO REMOVE IF SECURED TOO TIGHTLY. IN ADDITION, THE CLAMPS USED ON THE CATHETER HAVE BEEN REPORTED BY THE RN STAFF TO POP OPEN EASILY. IT IS NOT ALWAYS EASY TO SEE THAT THEY ARE OPEN.