MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
Received Aug 6, 2021 · Event occurred Jul 1, 2021
Report 3002807637-2021-00022 · MDR key 12289035
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Vyaire Medical Inc.Model number
MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLECatalog number
8003138
Product problems
- Leak/Splash
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE EXPERIENCED LEAK IN THE SYSTEM WHILE CONNECTED TO ANAESTHESIA MACHINE DUE TO SMALL CRACKS OBSERVED IN CANISTERS. ADDITIONAL MEDISORB CANISTERS HAD TO BE LOCATED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Additional Manufacturer Narrative
RESULT OF INVESTIGATION: A SAMPLE WAS RETURNED OF LOT 5120720 WHICH HAD CATASTROPHIC DAMAGE TO ONE OF THE FEET OF THE DEVICE ALLOWING MATERIAL TO FALL OUT LEAVING INVESTIGATOR UNABLE TO PERFORM A LEAK TEST AND ASCERTAIN WHERE THE ORIGINAL LEAK WAS COMING FROM. IT IS UNKNOWN WHETHER THIS HAPPENED ON ROUTE TO CUSTOMER OR ON ROUTE BACK TO INVESTIGATOR. UNABLE TO DETERMINE FAILURE DUE TO A DAMAGED RETURN SAMPLE.