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Model Number WNDACT |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problem
Necrosis (1971)
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Event Date 10/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided, it could not be determined that the alleged necrotic tissue and subsequent debridement were related to the activ.A.C.¿ therapy system.The nurse could not determine if the activ.A.C.¿ therapy system caused or contributed to the wound deterioration, and the patient continued to use the activ.A.C.¿ therapy system with subsequent wound progress noted.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 08-oct-2020, the following information was reported to kci by the nurse: the patient's periwound allegedly developed necrotic tissue and the patient was sent to the hospital.The vascular consultant noted the patient's wound will require removal of the necrotic tissue.On 03-nov-2020, the following information was reported to kci by the nurse: the patient was reportedly discharged home with an activ.A.C.¿ therapy system, and upon subsequent follow up, devitalized tissue was allegedly observed in the wound which required surgical debridement.The activ.A.C.¿ therapy system was subsequently re-applied, and the patient's wound is showing progress.The nurse could not determine the if the activ.A.C.¿ therapy system caused or contributed to the wound deterioration.No additional information was provided.A device evaluation for the activ.A.C.¿ therapy system is pending completion.
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Event Description
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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) 2020, 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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Based on the additional information provided regarding the device, kci's assessment remains the same; it could not be determined that the alleged necrotic tissue and subsequent debridement were related to the activ.A.C.¿ therapy system.The device passed quality control checks before and after patient placement.
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Search Alerts/Recalls
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