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It was reported that the patient felt like they were laying on the frame of the centrella bed with no support from the pro+ therapy surface.It was unknown how long the patient was on the mattress.On an unreported date, the patient developed a stage 3 pressure injury.The patient was reported to be alert, self-turning, and able to get out of bed with assistance.The bed was removed from service for inspection by baxter.No additional information was provided.The following additional information was obtained from the facility¿s wound care nurse.The patient in this event was a 77-year-old male weighing 65 kg with a medical history of decreased mobility, coronary artery disease, diabetes mellitus, heart disease, hyperlipidemia, and hyperthyroidism.On (b)(6) 2023, the patient was evaluated in the emergency department (ed) and admitted for abnormal labs.The patient remained in the ed from on (b)(6) 2023 before he was moved to the "k10" unit of the hospital on (b)(6) 2023.The patient's braden score on admission was 18; on (b)(6) 2023: 19, and on (b)(6) 2023: 16.On (b)(6) 2023, a photo of the patient's sacrum showed redness and a possible open area.On (b)(6) 2023, the wound care nurse assessed a stage 3 sacral pressure injury, which was treated with mepilex.The patient's mobility had increased since admission and he was ambulating in his room from the bathroom to bed upon arrival of the wound care nurse.The patient verbalized (for the first time since he was admitted) that the mattress was uncomfortable, and the wound care nurse noted the center of the mattress appeared to be deflated.No device alarms were noted.That same day, the wound care nurse requested the bed be removed and replaced.On (b)(6) 2023, the patient was discharged.The patient was readmitted to the hospital on an unreported date for an unreported reason and there was no documentation in the patient's emr of the stage 3 sacral pressure injury; therefore, the wound care nurse assumed the injury healed.No additional information was provided.The centrella® smart+ bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.It is intended for a broad patient population as determined appropriate by the caregiver or institution.It is intended for patient populations weighing at least 70 lb (32 kg) and is capable of supporting patients up to 500 lb (227 kg).The hillrom pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.If the deformity is on the mattress, determine the amount of deformity by laying a straight edge across the mattress and measuring the distance of the largest gap in the patient area.Some deformation is normal as mattresses age.Determine if the deformation is excessive per facility standards.Replace or repair as necessary.The development of pressure injuries is multifactorial and cannot only be attributed to the performance of the surface or the centrella bed.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.The baxter service technician inspected the bed and found that the hose xp w/cuffs was disconnected from the blower box.The technician reconnected the hose to the blower box and the issue was resolved.The technician ran the bed overnight with a weight of 100 lbs and the device functioned as designed.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.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.The ultimate cause of the reported event is undetermined, but likely multifactorial due to the patient¿s medical history, and decreased mobility.Due to the ongoing investigation, at this time baxter is unable to rule out that the bed caused or contribute to the serious injury.The complaint record will be reassessed upon receipt of additional information.Based on this information, no further action is required.
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29feb2024, update clinical evaluation: the baxter service team inspected the bed and found a disconnected hose to the microclimate management (mcm) cover.A secondary hose was still connected, and the surface was still receiving air but at a reduced capacity.The mattress uses foams of different densities with various constructions and zones to optimize patient support and comfort while distributing interface pressure (patient weight) over as much patient contact area as possible.The mattress provides self-adjusting technology to achieve inner core pressure redistribution when a patient is on/off the mattress.The pro+ mattress provides an optional mcm feature that helps decrease localized heat and moisture buildup that occurs between the patient and the mattress.In combination with patient weight, the mcm section likely did not provide full flow, however, the disconnected hose would be unlikely to impact the working cushion or support surface.It is unlikely that the pro+ mattress caused or contributed to the stage 3 pressure injury.
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