inforMED
MalfunctionKPF

FREEDOM CYCLER PD+

Received Jan 11, 2007 · Event occurred Dec 16, 2006

Report 2937457-2007-00001 · MDR key 810092

Device

Generic name

Peritoneal Dialysis Cycler

Model number

PD+ IQCARD

Catalog number

NA

Lot number

NA

Product problems

  • Blank screen
  • Loss of Power
  • Improper or Incorrect Procedure or Method

Patient

37 YR

  • Abdominal Pain
  • Discomfort

Narrative

Description of Event or Problem

A HOME PERITONEAL DIALYSIS PT REPORTED THAT HE WOKE UP AROUND 3:30 A.M. WITH STOMACH DISCOMFORT DURING HIS CCPD TREATMENT. HE NOTICED THAT THE SOLUTION BAGS WERE EMPTY AND THE CYCLER SCREEN WAS BLANK. HE TRIED TO POWER IT BACK ON, BUT WAS UNABLE TO RESTORE POWER TO THE CYCLER. HE REMOVED THE TUBING FROM THE LOWER VALVE BOX TO DRAIN THE SOLUTION FROM HIS ABDOMINAL CAVITY. THE DRAIN AMOUNT IS NOT KNOWN. SINCE HE WAS NOT ABLE TO COMPLETE HIS TREATMENT, IT IS ESTIMATED THAT HE WAS FILLED WITH AT LEAST TWICE THE AMOUNT OF HIS FILL VOLUME.