inforMED
MalfunctionKDZ

PLUM XLM SINGLE CHAN

Received Aug 22, 2003 · Event occurred Aug 1, 2003

Report 2921482-2003-00442 · MDR key 480732

Device

Generic name

Infusion Pump

Model number

NA

Catalog number

11859

Lot number

NA

Product problems

  • Failure to Deliver

Patient

*

  • Overmedicated
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

REPORT RECEIVED OF A PATIENT RECEIVING AN OVER-DELIVERY OF CARDIZEM. THE DEVICE WAS PROGRAMMED TO DELIVER A 100ML BAG OF CARDIZEM AT A RATE OF 10ML/HR. THE CUSTOMER COULD NOT RECALL THE INFUSION START TIME. IT WAS REPORTED THAT THE NURSE LEFT THE PATIENT'S ROOM AND APPROXIMATELY FIVE MINUTES LATER THE PUMP ALARMED THAT THE INFUSION WAS COMPLETE. THE CUSTOMER HAD NO SPECIFIC PATIENT INFORMATION; HOWEVER, IT WAS REPORTED THAT THE PATIENT'S VITAL SIGNS REMAINED STABLE AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.