UNSPECIFIED PLUM SET
Received May 11, 2023 · Event occurred Mar 6, 2023
Report 9615050-2023-00134 · MDR key 16911155
Device
Generic name
Unspecified
Manufacturer
Icu Medical Costa Rica Ltd.Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- Chemical Exposure
- Chemical Exposure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED PLUM SET WITH LEAKED AN UNSPECIFIED CHEMO DRUG DURING THE NIGHT SHIFT, AROUND 11:30 PM. THE PATIENT'S FAMILY WENT TO THE NURSE STATION AND INFORMED THE NURSES THAT THE C/T LINE WAS DRIPPING. THE NURSE OBSERVED THAT THERE WERE DROPLETS APPEARING AT THE VENT HOLE WHEN VISITING THE PATIENT'S UNIT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.