​Edwards—VAMP Jr. Blood Sampling Systems and TruWave/VAMP Jr. Pressure Monitoring Sets: Tubing May Detach

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Problem: ​In a May 26, 2021, Urgent Medical Device Recall letter submitted by an ECRI member hospital, Edwards states that the pressure tubing of the above sets may detach, potentially leading to blood loss that may necessitate transfusion. If this problem occurs during use, it would cause a change in the pressurization of the system, altering the pressure waveform and losing the ability to monitor arterial pressures. This would trigger an alarm to the bedside monitor, immediately alerting the user. Edwards also states that it received eight customer reports of this problem; however, the firm...