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Model Number VACDSP |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Wound Dehiscence (1154); Sepsis (2067)
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Event Date 01/01/2007 |
Event Type
Death
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Manufacturer Narrative
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Date of event: the specific date of the patient expiration was not provided.The time period 2007 was provided in the article, therefore, 01-jan-2007, was utilized.The abthera¿ open abdomen dressing identifier was not provided, and was not returned; therefore, a device history record review and a device evaluation could not be performed.Based on the information provided, kci determined that the alleged dehiscence, sepsis and patient expiration were due to use error as the dressing technique used by the author, described as modified tnp, was not placed according to manufacturer's recommendations.This event is being reported due to potential use error.Device labeling, available in print and online, states: warning: review all abthera¿ negative pressure therapy system saftey information before beginning wound preparation.Warning: review all abthera¿ negative pressure therapy system safety information before beginning wound preparation prior to application, please refer to the important safety information for the abthera¿ open abdomen negative pressure therapy system located in appendix 1.Also, for detailed instructions for use, please refer to the abthera¿ open abdomen negative pressure therapy system instructions for use included with each abthera¿ dressing and therapy units.Infection: infected abdominal wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as patient condition, wound condition and treatment goals.Refer to dressing application instructions for details regarding dressing change frequency (see pages 11-14).Prior to application, please refer to the important safety information for the abthera¿ open abdomen negative pressure therapy system located in appendix 1.Also, for detailed instructions for use, please refer to the abthera¿ open abdomen negative pressure therapy system instructions for use included with each abthera¿ dressing and therapy units.
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Event Description
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On 29-apr-2022, the following information was received by kci after a review of journal article, steenvoorde p., den outer a., neijenhuis p.Stomal mucocutaneous dehiscence as a complication of topical negative pressure used to treat an open abdomen: a case series.Ostomy/wound management 2009;55(6):44-8, which noted the following: the patient mr.K., a 59-year-old male with sigmoid cancer, ileus and ingrowth in the jejunum addressed with en bloc resection.The patient experienced anastomotic failure and underwent colostomy placement, and despite this surgery, the patient's laparostomy wound dehisced in the icu [intensive care unit].Fecal material leaked into the abdominal cavity, and the patient experienced septicemia necessitating antibiotic treatment, open abdominal treatment and several subsequent laparostomies.The patient reportedly passed away within a week of the complication.The authors reportedly cut the primary drape of the tnp dressing to create two dressing flaps that could be draped around the stoma.The author noted it cannot be determined with certainty that the observed stoma complications were caused by tnp dressing as stoma complications occur regularly, regardless of tnp use.However, this complication was not observed in other patients with colostomies and an open abdomen who were not treated in the icu with tnp and did not occur before provision of tnp, leading the authors to conclude that complications were the result of the tnp dressing, not something related to surgery.No additional information was provided.The abthera¿ open abdomen dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.
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Manufacturer Narrative
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Mdr-3009897021-2022-00095 submitted on 25-may-2022 noted the following: b5: describe event or problem: the abthera¿ open abdomen dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.D1: suspect medical device: abthera¿ open abdomen dressing.G4: premarket identification: k090489.Device labeling, available in print and online, states: warning: review all abthera¿ negative pressure therapy system safety information before beginning wound preparation.Prior to application, please refer to the important safety information for the abthera¿ open abdomen negative pressure therapy system located in appendix 1.Also, for detailed instructions for use, please refer to the abthera¿ open abdomen negative pressure therapy system instructions for use included with each abthera¿ dressing and therapy units.Infection: infected abdominal wounds should be monitored closely and may require more frequent dressing changes than noninfected wounds, dependent upon factors such as patient condition, wound condition and treatment goals.Refer to dressing application instructions for details regarding dressing change frequency.Corrections: b5: describe event or problem: the v.A.C.® abdominal dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.D1: suspect medical device: v.A.C.® abdominal dressing.G4: premarket identification: k022011.Device labeling unavailable as device was made obsolete december 2015.Based on the corrections provided, kci's assessment remains the same; it was determined that the alleged dehiscence, sepsis and patient expiration were due to use error as the dressing technique used by the author, described as modified tnp, was not placed according to manufacturer's recommendations.This event is being reported due to potential use error.
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Event Description
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The v.A.C.® abdominal dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.
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Search Alerts/Recalls
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