AUDIENCE: Risk Manager, Nursing, Pediatrics, Biomedical Engineer
ISSUE: Fisher & Paykel Healthcare received 24 reports in which the affected prongs detached from the nasal tubing during use, especially when mucous and/or moisture are present. When the affected prongs detach from the nasal tubing, therapy is likely to be interrupted. This may cause low blood oxygen (hypoxemia). The detached prongs may enter an infant’s mouth and present a potential risk of choking and airway obstruction. The use of the affected product may cause serious adverse health consequences, including death.
See the recall notice for a list of affected model and lot numbers.
BACKGROUND: The Nasal CPAP Prongs connect to the Fisher and Paykel Healthcare FlexiTrunk Patient Interface. The prongs are placed in the patient’s nostrils to deliver continuous positive airway pressure (CPAP) which involves passing air through an infant’s nose. The prongs are used in patients weighing up to 22 pounds in a hospital or clinical setting where the patient is monitored by trained medical staff. The device is not intended to be used as a life supporting device.
RECOMMENDATION: Starting April 11, 2014, Fisher & Paykel Healthcare sent its customers an Urgent Medical Device Recall letter. The letter identified the product, problem, and actions to be taken, which include:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
[05/23/2014 - Recall Notice - FDA]