MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE
Received May 5, 2020 · Event occurred Mar 25, 2020
Report 3002807637-2020-00005 · MDR key 10026193
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Vyaire MedicalModel number
MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLECatalog number
8003138
Lot number
8881119
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THE PRODUCT SAMPLE AND PHOTO IS AVAILABLE FOR ANALYSIS. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE FOR EVALUATION. ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE MEDISORB¿ MULTIABSORBER CANISTER HAS A GAP AT THE BOTTOM WHICH LEAD TO LEAKAGE. THE EVENT OCCURRED WHILE CONNECTED TO A PATIENT HOWEVER THE CUSTOMER CONFIRMED THAT NO PATIENT HARM WAS ASSOCIATED ON THIS EVENT.
Additional Manufacturer Narrative
DEVICE EVALUATION: G4, G7, H2, H3, H6 AND H10. RESULT OF INVESTIGATION: PHOTO PROVIDED CONFIRMED THE REPORTED FAILURE. HOWEVER, INVESTIGATION REVEALED THAT ALL UNITS UNDERGO LEAK TESTING AFTER MANUFACTURE AND BEFORE PACKAGING. ANY PRODUCT FOUND TO BE LEAKING IS AUTOMATICALLY REJECTED AND DISCARDED. ALSO, DEVICE HISTORY REVIEW REVEALED NO ISSUES, AND ALL UNITS PASSED TESTING. AS SUCH, THE CRACK LEADING TO LEAKAGE IS MOST LIKELY DUE TO THE CANISTER BEING SUBJECTED TO A SIGNIFICANT FORCE AFTER THE 100% IN LINE LEAK CHECK.