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Model Number WNDFRE |
Device Problems
Alarm Not Visible (1022); Suction Problem (2170); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: the date of the graft failure is unknown.(b)(6) 2020 is the date the technical issues were alleged.Based on information provided, it cannot be determined that the alleged graft failure is related to the activ.A.C.¿ therapy system.The nurse could not determine if the graft failure was due to the location of the wound, tobacco use or the activ.A.C.¿ therapy system.It is unknown if and what medical or surgical intervention was performed.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.
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Event Description
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On 04-sep-2020, the following information was reported to kci by the nurse: the activ.A.C.¿ therapy system was applied to the patient's split thickness graft.The device produced alarms but allegedly displayed a 0 mmhg pressure reading.On 14-sep-2020, the following information was reported to kci by the nurse: the activ.A.C.¿ therapy system reportedly produced multiple audible alarms with allegedly no visual reading of the type of alarm and displayed a 0 mmhg pressure reading.The nurse also reported that the patient has an extensive graft, and the area near the groin allegedly did not take.The nurse noted the patient is a smoker and that this is a difficult area for the wound/graft as this is a high mobile area, but could not determine if the graft failure was due to the activ.A.C.¿ therapy system.No additional information was provided.On 28-jul-2020, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2020, the device was placed with the patient.On 11-sep-2020, the device was tested per quality control procedure by kci service center and the unit passed the quality control checks and met specifications.Additionally, on 02-oct-2020, the device was tested per quality control procedure by kci quality engineering and the unit passed the quality control checks and met specifications.The device passed all functional testing including producing alarms as expected and no unexpected alarms.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.
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Event Description
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(b)(6) 2021, the following information was reported to kci: the v.A.C.Freedom¿ therapy system was allegedly not charging.On (b)(6) 2021, the following information was reported to kci by the wound care nurse: on (b)(6) 2021, the v.A.C.Freedom¿ therapy system was allegedly not charging.The v.A.C.Freedom¿ therapy system was replaced with an activ.A.C.¿ therapy system which was not compatible with the v.A.C.Freedom¿ canister.The patient subsequently removed the v.A.C.Freedom¿ therapy system which allegedly caused the patient's skin graft to fail.On (b)(6) 2021, the following information was reported to kci by the wound care nurse: the alleged malfunction of the v.A.C.Freedom¿ therapy system required the request for a replacement unit.The activ.A.C.¿ therapy system replacement was considered an incomplete order, and the v.A.C.® dressings were removed allegedly causing the patient's graft to fail.On (b)(6) 2020, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2020, the device was placed with the patient.On (b)(6) 2021, the device was tested per quality control procedure by kci quality engineering 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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Mdr-3009897021-2021-00001_121595-iss submitted on 12-feb-2021 noted the incorrect information in multiple sections.See below for the corrected fields.Corrections: a5: ethnicity: remove check, unknown.A6: race: remove check, unknown.B3: date of event: (b)(6) 2021.D4: model #: wndfre; catalog #: 320001 serial #: vcek3619; unique identifier (udi)#: (b)(4).D9: device available for evaluation - returned to manufacturer 05-jan-2021.G3: date received by manufacturer: 05-jan-2021.G4: premarket identification: k120033.H4: device manufacture date: 15-sep-2006.H6: adverse event problem: health effect - impact code: 4648.Medical device problem code: 2993.H10 correction: based on the corrections and information provided, it cannot be determined that the alleged graft failure is related to the v.A.C.Freedom¿ therapy system.The alleged graft failure did not require medical or surgical intervention, and it is unknown if a non-adherent dressing was applied directly over the graft.Device labeling, available in print and online, states: warnings.Keep v.A.C.® therapy on: never leave a v.A.C.® dressing in place without active v.A.C.® therapy for more than two hours.If therapy is off for more than two hours, remove the old dressing and irrigate the wound.Either apply a new v.A.C.® dressing from an unopened sterile package and restart v.A.C.® therapy; or apply an alternative dressing at the direction of the treating physician.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.Selecting an appropriate foam dressing: the v.A.C.® granufoam¿ dressings can be used over grafts only when there is a non-adherent dressing placed directly over the graft.Clinical considerations: -grafts, either native vessel or prosthetic, should be covered by well-vascularized tissue.Use a thick layer of natural tissue should provide the most effective protection, ideally a muscle flap or fascia prior to treatment with v.A.C.® therapy.The v.A.C.® granufoam¿ dressing should not be used directly on top of a graft, exposed vessel or anastomic site.In exceptional cases, for example, when closure over the native vessel with tissue or muscle is not possible, bioengineered tissue or multiple layers of non-adherent dressing material should be applied between the graft and v.A.C.® granufoam¿ dressing or v.A.C.® whitefoam¿ dressing as an intervening layer.Deterioration of the wound: 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: if available on the therapy unit, check the therapy history log 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, 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 bed.Meshed grafts: 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.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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