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Model Number WNDARM |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided on 14-sep-2017, kci is reporting this event due to the patient's report of a wound related hospital admission, however, as of 14-oct-2017, kci had no indication from the information provided to suggest that the activ.A.C.¿ ion progress¿ remote therapy monitoring system caused or contributed to the admission.A review of records provided on the date of activ.A.C.¿ ion progress¿ remote therapy monitoring system placement exhibited a recent and extensive surgical history.Kci could not determine that the alleged event was related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Based on the additional information obtained on 22-jul-2019, the nurse confirmed the hospital admission was unrelated to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Kci has deemed this event not reportable based on the information received on 22-jul-2019.Device labeling, available in print and online, 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.
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Event Description
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On 14-sep-2017, the following information was provided to kci by the patient: the patient was admitted to the hospital for a wound related issue.On 22-july-2019, the following information was provided to kci by the nurse: the hospital admission was not related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Per review of records provided on 01-sep-2017, the physician noted the patient has a significant vascular history including a left ax-fem [axillofemoral] bypass and has required more than 15 thrombectomies."just last week he underwent a thrombectomy of his left ax-fem graft.Still does not have pulses in the lle [left lower extremity].He did not take his lovenox [anticoagulant] as prescribed and his coumadin [anticoagulant] had just been started which led to a subtherapeutic inr [international normalized ratio].This likely led to another thrombosis of his ax fem graft." on 31-aug-2017, a physician noted to continue with wound vac therapy.Additional records provided on 22-jul-2019 noted that on (b)(6) 2017, the patient was admitted to the hospital (surgery admit) with "reason: surgical procedure: excision infected left axillary femoral graft with core matrix patch angioplasty." on 30-aug-2017, 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) 2017, the device was placed with the patient.On 02-nov-2017, the device was tested per quality control procedure by 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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Search Alerts/Recalls
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