NOT PROVIDED
Received Jan 18, 2023 · Event occurred Jan 1, 2023
Report 9615050-2023-00011 · MDR key 16195054
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical Costa Rica Ltd.Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Air/Gas in Device
- Air/Gas in Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COMPLAINT OF ALLOWS AIR IN LINE COULD NOT BE CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED.
Additional Manufacturer Narrative
EVALUATION OF THE DEVICE IS ANTICIPATED. HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER.
Description of Event or Problem
THE EVENT INVOLVED AN UNKNOWN SAPPHIRE SET. THE CUSTOMER REPORTED THAT THEY OBSERVED AIR BUBBLES IN THE TUBING DESPITE PRIMING. THE CUSTOMER STATED THAT THE PRODUCT WAS EITHER LOT: 484956 (SAPPHIRE PRIMARY PIGGYBACK SET, 15 MICRON FILTER IN SIGHT CHAMBER, 2 CLAVE Y-SITES, 281 CM) OR LOT: 5287480 (SAPPHIRE PRIMARY 1.2 MICRON FILTER SET, NON-VENTED, CLAVE Y-SITE, 289 CM). THE DATE OF THE EVENT WAS UNKNOWN. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT IS UNKNOWN. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.