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Date of event: the specific date of the event is unknown.The nurse stated that the event occurred between (b)(6) 2021 and (b)(6) 2021 thus (b)(6) 2021 was utilized.Other (code unspecified) the device is a customer owned device and the identifiers were not provided.Based on the information provided, it cannot be determined that the alleged events are related to the v.A.C.Ulta¿ negative pressure wound therapy system.The initial wound type was removal of infected hardware, and the patient was on intravenous antibiotics prior to initiating v.A.C.® therapy.It is unclear if the infection resolved prior to the alleged events.The v.A.C.Ulta¿ negative pressure wound therapy system serial number and the prevena customizable¿ dressing lot number were not provided and the device/dressing have not been returned; therefore, a device history record review and a device evaluation could not be performed.The nurse confirmed there were no malfunctions that occurred during placement.Device labeling, available in print, states: if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.-assess for osteomyelitis and, if present, treat accordingly.Clinical considerations: in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.Infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions and treatment goals.Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.
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On (b)(6) 2021, the following information was reported to kci by the nurse: the prevena¿ dressing was placed on the patient in the or [operating room].The patient's wound allegedly dehisced requiring an irrigation and debridement, wash out and v.A.C.® therapy placement.On (b)(6) 2021, the following information was reported to kci by the nurse: on (b)(6) 2021, the v.A.C.Ulta¿ negative pressure wound therapy system with prevena¿ customizable¿ dressing was applied to the 70 year old female patient with a thoracic to lumbar incision, and was subsequently removed on (b)(6) 2021.The date of event was noted as (b)(6) 2021.The outcome and description of the event noted as "open wound at bedside, v.A.C.Applied, more deterioration, back to or for i&d [irrigation & debridement] + washout, large defect on v.A.C.® therapy, prolonged hospital stay, iv abx [intravenous antibiotic], pain and suffering." on (b)(6) 2021, the following information was provided to kci by the nurse: during the time period from (b)(6) 2021 and (b)(6) 2021, the wound was reportedly leaking and dehisced.The physician opened the patient's wound and identified a 3 cm tunnel.The v.A.C.Ulta¿ negative pressure wound therapy system with v.A.C.® granufoam¿ dressing and v.A.C.Whitefoam¿ dressing was applied.Approximately two weeks later, the patient's wound allegedly got larger and the tunneling was deeper.The patient underwent surgery to remove infected hardware on (b)(6) 2021 prior to initiating v.A.C.® therapy.The patient was placed on intravenous antibiotic therapy during the initial surgery and is currently still on them.The patient is currently on v.A.C.® therapy.The v.A.C.® granufoam¿ dressing and v.A.C.Whitefoam¿ dressing identifiers are unknown.The nurse confirmed there were no v.A.C.® therapy malfunctions or dressing malfunctions that occurred during placement.The nurse stated the prevena¿ dressing did not prevent the event from occurring.The v.A.C.Ulta¿ negative pressure wound therapy system serial number with the prevena customizable¿ dressing lot number were not provided and the device/dressing have not been returned; therefore, a device history record review and a device evaluation could not be performed.Refer to mdr-3009897021-2021-00154 for event with v.A.C.Ulta¿ negative pressure wound therapy system with prevena¿ customizable¿ dressing.Refer to mdr-3009897021-2021-00155 for event with v.A.C.Ulta¿ negative pressure wound therapy system with v.A.C.® granufoam¿ dressing and v.A.C.Whitefoam¿ dressing.
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