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Model Number WNDINF |
Device Problems
Increase in Pressure (1491); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fistula (1862)
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Event Date 02/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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Based on information provided, it cannot be determined that the alleged fistula is related to the infov.A.C.¿ therapy system.It is unknown if either hospitalization or medical/surgical intervention was required.The physician noted that the factors that contributed to the fistula formation could not be identified.Kci has made multiple unsuccessful attempts to obtain additional clinical information with no response.No additional information is available.Device labeling, available in print and online, states: contraindications.V.A.C.® therapy is contraindicated for patients with: non-enteric and unexplored fistulas.Precautions: continuous versus intermittent/dpc v.A.C.® therapy: continuous, rather than intermittent/dpc, v.A.C.® therapy is recommended over unstable structures, such as unstable chest wall or non-intact fascia, in order to help minimize movement and stabilize the wound bed.Continuous therapy is also generally recommended for patients at increased risk of bleeding, highly exudating wounds, fresh flaps and grafts with acute enteric fistulae.Enteric fistulas: wounds with enteric fistulas required special precautions to optimize v.A.C.® therapy.V.A.C.® therapy is not recommended if enteric fistula effluent management or containment is the sole goal of therapy.Wound specific information: enteric fistula.In certain circumstances, v.A.C.® therapy may help to promote healing in wounds with an enteric fistula.If considering v.A.C.® therapy involving enteric fistula, it is recommended to seek support from and expert clinician.V.A.C.® therapy is not recommended or designed for fistula effluent management or containment, but as an aid to wound healing in and around the fistula.The goal of therapy depends on whether the fistula being treated is considered acute or chronic.For acute fistula, the goal is to promote wound healing to enable closure of the acute enteric fistula.For chronic fistula, the enterocutaneous fistula is segregated from the surrounding or adjacent abdominal wound and v.A.C.® therapy is applied to the wound.The effluent from the fistula is diverted into another containment system.This allows time for the patient's overall health to stabilize and sufficient healing to take place to enable subsequent surgical repair.Fistula management: acute candidate selection: enteric fistula: acute formation: no evidence of epithelial cells/growth on opening of fistula.Fistula opening must be easily visualized and accessed.Npo (nothing by mouth) tpn (total parental nutrition).Minimal to moderate amounts of effluent.Effluent is thin to slightly viscous consistency.Chronic candidate selection; enteric fistula - non-surgical candidate; chronic formation: evidence of epithelial cells/growth (stomatization); mouth of fistula must be easily visualized and accessed; npo (nothing by mouth); tpn (total parental nutrition).
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Event Description
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On (b)(6) 2019, the following information was reported to kci by the physician: the patient was using the infov.A.C.¿ therapy system with the abthera¿ dressing.The customer alleged the unit was not maintaining the system configuration as well as exhibiting a "high pressure" message.On (b)(6) 2019, during the patient's dressing change, the patient's clinical condition allegedly worsened.On (b)(6) 2019, the following information was reported to kci by the physician: the patient's worsening condition was noted as a fistula.Infov.A.C.¿ therapy was discontinued.On 25-mar-2019, the following information was reported to kci by the physician: in case the fistula drains again, the physician made a "raffia" in the fistula and inserted a drain in the cavity.The factors that contributed to the fistula formation could not be identified, but the medical team questioned if the negative pressure was correctly applied on the abdomen.The patient presented an important improvement after four medical procedures and now is being discharged.A device evaluation of the infov.A.C.¿ therapy system is currently pending completion.An abthera¿ dressing lot number was not provided, therefore a device history review could not be performed.
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Event Description
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The infov.A.C.¿ therapy unit serial number (b)(4) passed quality control checks and met specifications on 04-dec-2018 before placement with the patient.After the patient placement on (b)(6) 2019, kci brazil replaced the coin cell battery which controls the date, time and language displayed by the unit.The coin cell battery does not affect the device's ability to maintain negative pressure.The device logs were reviewed by kci during further evaluation of the unit on 04-apr-2019.There was no evidence of "high pressure" messages in the logs.There was evidence of low pressure alarms and alerts which notify the user that the device is detecting a pressure that is below the pressure range set by the user.During quality control (qc) checks performed, there were no operational malfunctions or alarm conditions experienced by the device during qc testing.There was no fault found with the device associated with negative pressure.The cause of the pressure alarms was not determined.
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Manufacturer Narrative
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Based on information the additional information obtained from the device evaluation, kci's assessment remains the same; it cannot be determined that the alleged fistula is related to the infov.A.C.¿ therapy system.
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Search Alerts/Recalls
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