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Model Number WNDARM |
Device Problems
No Audible Alarm (1019); Alarm Not Visible (1022); Suction Problem (2170)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/20/2023 |
Event Type
Injury
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Event Description
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On 23-jan-2023, the following information was provided to kci by the nurse: the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly malfunctioned, did not alarm, and the patient's skin graft failed.The physician indicated the device kept the wound too wet.On 09-feb-2023, the following information received via clinical records from physician were reviewed: on 17-jan-2023, patient underwent skin grafting.The activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed (b)(6) 2023.Appeared the graft partially took.The wound bed appeared too moist and there is question as to if the activ.A.C.¿ therapy system was working properly.The wound bed is clean without signs of infection.New activ.A.C.¿ ion progress¿ remote therapy monitoring system delivered to patient home to be restarted at wound clinic.Will follow up to discuss repeat skin grafting.On 10-feb-2023, the following information was provided to kci by the nurse: v.A.C.® therapy was restarted (b)(6) 2023.Patient's wound is improving.On 20-feb-2023 a device evaluation was completed by kci quality engineering.On 08-dec-2022, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2023, the device was placed with the patient.On 20-feb-2023, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.
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Manufacturer Narrative
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Based on the information provided, it cannot be determined that the alleged graft failure is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before and after patient placement.Device labeling, available in print and online, states: continuous therapy is also generally recommended for patients at increased risk of bleeding, highly exudating wounds, fresh flaps and grafts, and wounds with acute enteric fistulae.Continuous therapy for duration of 7 days with no dressing changes is also generally recommended for use of v.A.C.® therapy with a new graft placement.Apply v.A.C.® dressing immediately after graft placement and begin therapy as soon as possible.When using v.A.C.® granufoam¿ dressings, a non-adherent dressing should be placed directly over the graft / tissue.In general, the pressure setting used to prepare the recipient bed before grafting should be continued after grafting.Continuous therapy should be used to provide a constant bolster.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.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.
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Search Alerts/Recalls
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