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The customer reported that the pro+ surface¿s foam is ¿deflating at the sacral area¿ and a patient developed a ¿stage 3 mixed with a stage 2 left buttock pressure injury and deep tissue injury mixed with a stage 2 pressure injury on the right buttock, sacrum¿.This patient is a 61-year-old male admitted for a spinal abscess.This patient is noted to have a urinary foley and is ¿incontinent of stool.¿ upon admission (b)(6) 2023), this patient was noted to have ¿intact skin.¿ the patient¿s pressure injuries were reported to have been noted on (b)(6) 2024.The medical intervention for the reported pressure injuries included, a sacral dressing, nutritional support, repositioning every two hours, the introduction of an ehob waffle mattress overlay (third party), a ehob waffle cushion when up to chair, and a rectal tube for stool incontinence.The customer reported that upon the introduction of the mattress overlay, there was ¿significant improvement noted in the wound, and some resulted in closure¿ and that at the patient¿s discharge (b)(6) 2024), the patient had areas of healing and re-injury.This report was filed in our complaint handling system as complaint #(b)(6).
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The customer reported that the pro+ surface¿s foam is ¿deflating at the sacral area¿ and a patient developed a ¿stage 3 mixed with a stage 2 left buttock pressure injury and deep tissue injury mixed with a stage 2 pressure injury on the right buttock, sacrum¿.This patient is a 61-year-old male admitted for a spinal abscess.This patient is noted to have a urinary foley and is ¿incontinent of stool.¿ upon admission (b)(6), 2023), this patient was noted to have ¿intact skin.¿ the patient¿s pressure injuries were reported to have been noted on (b)(6), 2024.The medical intervention for the reported pressure injuries included, a sacral dressing, nutritional support, repositioning every two hours, the introduction of an ehob waffle mattress overlay (third party), a ehob waffle cushion when up to chair, and a rectal tube for stool incontinence.The customer reported that upon the introduction of the mattress overlay, there was ¿significant improvement noted in the wound, and some resulted in closure¿ and that at the patient¿s discharge (b)(6) 2024), the patient had areas of healing and re-injury.The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.The pro+ mattress is intended for use in healthcare environments and is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.The mattress supports patients weighing between 70 lb (32 kg) and 500 lb (227 kg).The pro+ mattress with advanced microclimate® technology (amt) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned.Additionally, the instructions for use (ifu) states the therapy surface is not a substitute for good nursing practices.Therapy modes should be used in conjunction with good assessment and protocol.Failure to follow good nursing practices may result in patient harm.The development of pressure injuries is multifactorial and cannot only be attributed to the performance of the surface or the pro+ surface.Pressure injuries can develop within 2-6 hours when capillaries supplying the skin and subcutaneous tissues are compressed, causing an obstruction in blood flow, which ultimately leads to tissue necrosis.Position changes are key to pressure injury prevention and treatment.These changes need to be frequent, repositioning needs to avoid stress on the skin, and body positions need to minimize the risk of pressure on vulnerable areas.Prevention of pressure injuries involves a multidisciplinary approach including rapid identification of at-risk individuals such as those with diabetes, incontinence, impaired mobility, peripheral vascular disease, etc., and exercising a vigilant prevention protocol consisting of skincare, nutritional assessment reducing mechanical load, and utilizing support surfaces.In this event, the patient was reported to have a stage 3, and two stage 2, and a deep tissue pressure injury to the buttocks, in which the intervention included the application of a sacral dressing, nutritional support, repositioning, and introduction of an accessory mattress cushion and chair cushion, which was noted to have led to ¿areas of healing along with re-injury¿ of the reported injuries.A stage 3 pressure injury is categorized as full-thickness tissue loss.Subcutaneous fat may be visible, but bone, tendon or muscle are not exposed.A stage 2 pressure injury is characterized by partial-thickness skin loss no deeper than the dermis and can include intact or ruptured blisters.Stage 2 pressure injuries can heal very rapidly, therefore, treatment is focused on nutrition to support wound healing and keeping the area protected/covered and clean.A deep tissue pressure injury (dti) is a persistent non-blanchable deep red, purple or maroon area of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues.Ulcers covered with slough or eschar are unstageable.Treatment can include frequent repositioning off the site of injury, good skin care, proper support surface selection, correcting any systemic issues or nutritional deficiencies and medical treatment from a wound care specialist.At times additional treatments can include prescribed antibiotic therapy and removal of dead tissue to promote healing and prevent or treat the infection.In some cases, a dti could resolve in few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they could develop into stage 3 or 4 (or unstageable) depending on the involvement of a deeper underlying structure.In this event, the patient required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, concluding a serious injury occurred in this case.Additionally, the reported ¿areas of re-injury¿ are ongoing therefore progression of the pressure injury to a severe state and permanent damage to a body structure cannot be excluded at this time.The ultimate cause of the reported event is undetermined.At the time of this evaluation, an inspection could not be performed as the customer has not identified the specific bed associated with this patient.Due to the ongoing investigation, at this time baxter is unable to rule out that the bed caused or contributed to the serious injury.The complaint record will be reassessed upon receipt of additional information.Based on this information, no further action is required.The complaint record will be reassessed upon receipt of additional information.
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