Sentec/Percussionaire is recalling Phasitron respiratory circuit kits after receiving a buyer grievance that the venturi part of the package might cease oscillating throughout use, leading to affected person oxygen desaturation, in line with an FDA alert.
The FDA experiences that the danger of failure is “particularly excessive for pediatric sufferers as a result of low pressures which might be related to this part failure.”
The FDA has recognized this as a Class I recall, cautioning that use of affected product might trigger severe hostile well being penalties, together with acute respiratory failure, hypoxia, hypercapnia, potential mind harm, coronary heart problems, elevated threat of pneumonia, and dying.
No reported accidents or deaths have been reported, the FDA stated within the alert.
The Phasitron respiratory circuit package is meant for use for steady, managed air flow of sufferers who’re unable to breathe on their very own. The venturi part of the Phasitron helps with the pulsing move of air/oxygen to the affected person.
Product Recall Info
- Product Names/Fashions and Half Numbers:
- Phasitron Equipment, VDR, Single Affected person A50094-D, A50094-D-5PK
- Distinctive System Identifier (UDI): 00849436000259
- Management Unit Tester A51001-VDR4
- VDR W/SWIVEL T SINGLE PATIENT PHASITRON PRT-991
- VDR4 HUMIDIFICATION ADAPTER KIT PRT-992
- VDR4 Humidification Equipment with Cross Tee PRT-993
- Phasitron Equipment, VDR, Single Affected person A50094-D, A50094-D-5PK
- Lot/Serial Numbers: See full checklist of affected units on the FDA web site.
What to Do
- Carefully monitor all sufferers who’re ventilated with Phasitron respiratory circuits which may be affected by this concern.
- Ensure that the venturi part of the Phasitron respiratory circuit in use is transferring by on the lookout for motion and listening for noise.
- Don’t use any Phasitron respiratory circuit that’s malfunctioning or doesn’t move the improved pre-check directions outlined beneath.
Extra info is obtainable on the FDA web site.
