The user states that the bigger better-bladder failed due to a leaking pigtail the unit was not returned for inspection and confirmation.This is the first and only complaint received for a leaking pigtail since implementation of a corrective action on 10/6/2017.Each unit is tested during the manufacturing process and no issues were reported.A review of the ohr found no evidence of nonconformities with no reported defects.Since implementation of the corrective action on 10/6/17, this is the only report of a leaking pigtail.Specifically, (b)(4) lots of better-bladders and bigger better-bladders have been manufactured with this complaint resulting in a defect rate of (b)(4).The leaking pigtail could not be confirmed and hence may have been caused by other factors.For example, the leak may have been due to a poor connection anywhere between the pigtail and the pressure transducer (e.G.Numerous stopcocks and numerous luer fittings) and not a leaking pigtail.Note the udi # is (b)(4).
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From medwatch report (b)(4): the bigger better bladder in the ecmo circuit has an air chamber on the outside for equilibrating the pressure during the run that ensures appropriate negative pressure on the system.During the previous night, specialist has trouble maintaining in the air chamber to the right pressure.They found the air chamber pigtail was leaking requiring the blabber to be changed on the circuit.The patient was off bypass for 1:20 (one minute 20 seconds) during the change, but tolerated the brief time without incident.Possibly a manufacturer defect.Event was related to a defective consumable which was replaced with no event.Machine did not malfunction-no further action by biomed.
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