PLUM A+ PUMP - MEDNET WIRELESS
Received Dec 6, 2005 · Event occurred Nov 16, 2005
Report 2921482-2005-00656 · MDR key 650408
Device
Product problems
- No Audible Alarm
- Blank screen
- Replace
- Self-Activation or Keying
Patient
*
- Therapy/non-surgical treatment, aborted/stopped
Narrative
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED THE DEVICE POWERED OFF BY ITSELF WHILE PLUGGED INTO AN AC OUTLET WITHOUT SOUNDING AN AUDIBLE ALARM TONE. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER A HYDRATION FLUID AND THE DELIVERY WAS STARTED WHILE THE DEVICE WAS PLUGGED INTO AN AC OUTLET. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. APPROX 1 MINUTE LATER, THE NURSE WENT BACK INTO THE PT'S ROOM AND NOTED THE DEVICE'S DISPLAY WAS BLANK AND THAT THE DEVICE HAD POWERED OFF BY ITSELF. NO AUDIBLE ALARM HAD SOUNDED. THE DEVICE WAS REMOVED FROM CLINICAL SVC. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED.