Angiojet equipment primed by rn prior to use of angiojet.When cassette placed in machine and door closed to load the cassette, machine did not recognize cassette.Door reopened and cassette reseated.Door closed and machine still did not recognize cassette in order to continue with priming.Door reopened and when cassette was visually examined, rn noted that something appeared different and, upon closer examination of "balloon" at top of metal plunger, a fluid leak was noted and small puncture was visible.Entire angiojet assembly was immediately removed from field and machine; replaced with new angiojet product which then immediately worked, priming correctly and no further difficulties were encountered for the rest of the case.Defective product was never loaded onto guidewire or inserted into patient prior to removal.Fda safety report id # (b)(4).
|