MalfunctionDTM
HBF 140 U-J QUART
Received Dec 30, 2013 · Event occurred Dec 3, 2013
Report 8010762-2013-00178 · MDR key 3639258
Device
Generic name
Quart Arterial Filter
Manufacturer
Maquet Cardiopulmonary AgModel number
NACatalog number
70103.1618
Lot number
70088677
Product problems
- Fluid/Blood Leak
- Leak/Splash
Patient
NA
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING PRIMING, LEAKAGE OF PRIMING LIQUID WAS OBSERVED. REF.: (B)(4).
Additional Manufacturer Narrative
(B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Remedial action
- Other