MEDISORB EF MULTI-ABSORBER, DISPOSABLE
Received Apr 1, 2020 · Event occurred Feb 21, 2020
Report 3002807637-2020-00004 · MDR key 9909109
Device
Generic name
Absorber, Carbon-dioxide
Manufacturer
Vyaire MedicalModel number
MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLECatalog number
M1173311
Product problems
- Chemical Problem
- Chemical Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THAT THE PRODUCT SAMPLE AND PHOTO IS AVAILABLE FOR ANALYSIS. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE FOR EVALUATION. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE MEDISORB EF MULTI-ABSORBER, DISPOSABLE SODA-LIME COLOR REMAINS WHITE WHILE THE INSPIRATORY C02 INCREASES TO 15%. THE CUSTOMER ADVISED THAT THEY HAD REPLACED THE CANISTER AND THE INSPIRATORY C02 BACK TO 0. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Additional Manufacturer Narrative
RESULTS OF INVESTIGATION: NO PHOTOGRAPHIC EVIDENCE WAS SUPPLIED AND NO SAMPLE WAS RETURNED. THEREFORE IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF FAILURE. THE MANUFACTURING SITE REVIEWED THE MANUFACTURING RECORDS WHICH INDICATE ALL UNITS PACKED PASSED 100% LEAK TEST AND VISUAL INSPECTION. A REVIEW OF THE BATCH DOCUMENTATION FOR LOT 1720519 FOUND NO ISSUES THAT COULD BE LINKED WITH FAILURES ON THIS BATCH. PRODUCTION QUALITY TESTS FOR LOT 1720519 SHOWED CO2 ABSORPTION OF 23.6 %, WHICH EXCEEDS THE MATERIAL SPECIFICATION REQUIREMENT OF 19%.