As reported, a patient was hospitalized and underwent treatment for hypothermia.A quattro catheter was placed in the patient's femoral vein for therapeutic ivtm treatment.The following day, saline bag found to be empty and was replaced.Next day, prior to catheter replacement, saline bag again found empty.At this point, leakage was suspected on a quattro catheter.No alarm was noted on the console and no saline leak was observed on the patient bed or on the floor.No known impact or patient consequence was reported.
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The reported complaint was confirmed.Visual examination found no physical damage.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a bond leak was observed on the distal balloon.During manufacturing all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Probable causes for the reported complaint can be a latent material defect.
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