MalfunctionDTP
VENOUS BUBBLE TRAP WITH & W/O BIOLINE COATING
Received Nov 26, 2014 · Event occurred Mar 20, 2012
Report 8010762-2014-00420 · MDR key 4278463
Device
Generic name
Defoamer, Cardiopulmonary Bypass
Manufacturer
Maquet Cardiopulmoary AgModel number
BO-HQV1519Catalog number
70104.9692
Product problems
- Break
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE CAUSE IS TOO LITTLE GLUE APPLIED DURING THE MANUFACTURING PROCESS. (B)(4).
Description of Event or Problem
ON (B)(6) 2012, (B)(6), REPORTED THAT THE VENOUS BUBBLE TRAP (VBT) IN THE BO-HQV1519 MECC SET (ARTICLE NUMBER: 70104.9692, SERIAL NUMBER: UNKNOWN) "ALWAYS BREAKS THE UPPER CONNECTION". (B)(4).