BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILE
Received Aug 7, 2014 · Event occurred Jul 8, 2014
Report 8010762-2014-00294 · MDR key 4219095
Device
Generic name
Venous Bubble Trap
Manufacturer
Maquet Cardiopulmonary AgCatalog number
70104.8887
Lot number
92125382
Product problems
- Suction Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE, ACCUMULATION OF AIR WAS OBSERVED AT THE LOWER SIDE OF THE DE-AIRING COCK OF THE DEVICE. THE AIR WOULD NOT EASILY DISAPPEAR WHEN THE DE-AIRING COCK WAS MANIPULATED. DEVICE USE WAS CONTINUED. NO PT EFFECT WAS REPORTED. (B)(4).
Additional Manufacturer Narrative
(B)(4). A HEALTH HAZARD EVAL WAS INITIATED AND THE HAZARD HAS BEEN DEFINED. BASED ON NEW INFO AVAILABLE 08/01/2014, A RE-ASSESSMENT OF THE REPORTING OBLIGATION WAS PERFORMED AND THIS EVENT WAS DETERMINED TO BE REPORTABLE. MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS AND AN INTERNAL PROCESS ((B)(4)) WAS INITIATED TO DETERMINE THE ROOT- CAUSE AND IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADD'L INFO BECOMES AVAILABLE.