The bag was retained by the user and sent to charter medical for investigation.The bag was visually inspected and 2 items of interest observed on the bag film located in the area below the left port tube.Film deformation (i.E.Stretched) in the area of base of the port tube, approximately 0.30-inch long.A film tear in the deformed area, which was approximately 0.03-inches in size.A film tear of the size observed on the returned sample would have likely resulted in a detectable leak during filling or thawing of the bag.The root cause of the film distortion or leak could not be conclusively determined.The film deformation under the right port tube suggests the bag may have encountered physical stress at some point, potentially while being handled when the bag was in the frozen state, although the exact point where the film deformation occurred is unknown.Since the film directly under the right port tube had indications of stress deformation, and the leak occurred after spiking, this would suggest the spiking process further exacerbated the film deformation and potentially resulted in the tear and leak.There are other causes that could potentially result in a film deformation and a tear: overfilling the bag.An overfilled bag could create resistance during insertion and removal of the bag from the metal cassette.Excessive air left inside the bag after filling, resulting in rapid expansion during thawing.Moisture on the exterior surface of the bag or cassette interior when the bag is inserted into the metal cassette.Moisture may cause the bag film to freeze to the interior cassette surface, thus potentially resulting in damage when the frozen bag is removed from the cassette.An unknown material anomaly.The product instruction for use sheet is provided with each cml-75ln device.Review of the ifu version provided with lot 145909 has the following precautions: "after freezing, do not handle excessively.Port tubes and film are fragile in the frozen state and breakage may occur.Handle with care." "do not overfill." "remove as much air as possible from the container." "ensure bag exterior and protective freezing cassettes are dry prior to initiating freezing protocol.Moisture on the exterior of the bag or on the cassette could cause adherence of the bag to the cassette resulting in difficulty of bag removal.".
|