MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
Received Jul 19, 2021 · Event occurred Jun 14, 2021
Report 3002807637-2021-00021 · MDR key 12189708
Device
Generic name
Absorbent, Carbon-dioxide
Model number
MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLECatalog number
8003138
Lot number
5090720
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
RESULT OF INVESTIGATION: NO SAMPLE AVAILABLE. THE PHOTOGRAPHIC EVIDENCE SUPPLIED CLEARLY SHOWS THAT THE CANISTER HAS SUSTAINED SIGNIFICANT DAMAGE ON THE LID. A CRACK ON THE CANISTER OF THIS NATURE WOULD INDICATE THAT THE MOST LIKELY CAUSE IS THAT THE CANISTER HAS BEEN SUBJECTED TO A SIGNIFICANT FORCE CONSISTENT WITH IT BEING DROPPED AT SOME POINT AFTER THE POINT OF INSPECTION AND PACKING. POINT AT WHICH DAMAGE OCCURRED NOT CONFIRMED. THEREFORE, ROOT CANNOT BE DETERMINED.
Additional Manufacturer Narrative
THE CUSTOMER STATED NO SAMPLE AVAILABLE. ONLY A PHOTO PROVIDED FOR INVESTIGATION. 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 DAMAGED ABSORBENT CANISTER. THERE WAS A BIG CRACK IN THE ABSORBER CAUSING A LEAK IN THE PATIENT CIRCUIT. AS AN INTERVENTION, THE PATIENT WAS INTUBATED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.