|
Model Number WNDINF |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fistula (1862); Bowel Perforation (2668)
|
Event Date 12/31/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Based on the information provided, it cannot be determined that the alleged fistula formation is related to the abthera¿ open abdomen negative pressure therapy system.It was noted that there was multiple trauma and damage control, and the patient was post-operative surgical resection of necrotic intestine.A protective layer was reportedly placed between the intestine and "foam" and adhesion was noted.The device was applied one day prior to identifying an alleged "pit hole." an evaluation of the device is pending completion.Device labeling, available in print and online, states: abthera¿ visceratl protective layer (vpl) application warning: the foam in the visceral protective layer is encapsulated for patient safety.Protect vital structures with open abdomen visceral protective layer at all times during therapy.Never place exposed foam material directly in contact with exposed bowel, organ, blood vessels or nerves.
|
|
Event Description
|
On 02-feb-2021, the following information was reported to kci: on (b)(6) 2020, abthera¿ open abdomen negative pressure therapy was applied to the patient post-surgical resection of necrotic intestine.On (b)(6) 2020, the abthera¿ open abdomen dressing was removed for follow up, and a "pit hole shaped" fistula located in the intestine directly under the protective layer was allegedly observed, and the intestine with the "pit hole" was removed.It was noted that a video recording exhibited no evidence of injury to the intestinal tract.On 23-feb-2021, the following information was provided to kci: the patient's initial operation was performed 90cm from the treitz ligament, and the alleged "pinhole" was located 75cm from the treitz ligament.Leakage from the small intestine was observed with limited contamination, and 20cm of the jejunum was resected.A protective layer was reportedly placed between the intestine and abthera¿ open abdomen dressing but adhesion between the intestine and protective layer was noted.The video recording reportedly exhibited that there were no injuries to the intestine from the use of forceps.It was also noted that multiple trauma and subsequent damage control were contributing factors.The patient has reportedly recovered.The abthera¿ open abdomen dressing was noted as "presumable discarded." a device evaluation of the abthera¿ open abdomen negative pressure therapy is currently pending completion.
|
|
Event Description
|
On 17-mar-2021, a device evaluation was completed by kci quality engineering.On 27-nov-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 18-jan-2021 the device was tested per quality control procedure by kci field service 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.Corrections: on 02-feb-2021, the following information was reported to kci: on (b)(6) 2020, the infov.A.C.¿ therapy system was applied.A device evaluation of the infov.A.C.¿ therapy system is currently pending completion.
|
|
Manufacturer Narrative
|
Mdr- 3009897021-2021-00041 submitted on 04-feb-2021 reported the following: b5 describe event or problem: on 02-feb-2021, the following information was reported to kci: on (b)(6) 2020, abthera¿ open abdomen negative pressure therapy was applied.A device evaluation of the abthera¿ open abdomen negative pressure therapy is currently pending completion.D1 brand name: abthera¿ open abdomen negative pressure therapy.D4: model #: wndabt.D8 was this device serviced by a third party?: yes.G4 pma/510(k): k083357.H10 additional manufacturer narrative: based on the information provided, it cannot be determined that the alleged fistula formation is related to the abthera¿ open abdomen negative pressure therapy system.Corrections: b5 describe event or problem: on 02-feb-2021, the following information was reported to kci: on (b)(6) 2020, abthera¿ open abdomen negative pressure therapy was applied.A device evaluation of the infov.A.C.¿ therapy system is currently pending completion.D1 brand name: infov.A.C.¿ therapy system.D4: model #: wndinf.D8 was this device serviced by a third party?: no.G4 pma/510(k): k063692.H10 additional manufacturer narrative: based on the information provided, it cannot be determined that the alleged fistula formation is related to the infov.A.C.¿ therapy system.Based on the corrections and additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged fistula formation is related to the infov.A.C.¿ therapy system.The device met quality control specifications before and after patient placement.Device labeling, available in print and online, states: enteric fistula, contraindications.V.A.C.® therapy is contraindicated for patients with: non-enteric and unexplored fistulas.Enteric fistulas: wounds with enteric fistulas required special precautions to optimize v.A.C.® therapy.V.A.C.® therapy is not recommended if enteric fistula effluent management or containment is the sole goal of therapy.Enteric fistula: in certain circumstances, v.A.C.® therapy may help to promote healing in wounds with an enteric fistula.If considering v.A.C.® therapy involving enteric fistula, it is recommended to seek support from and expert clinician.V.A.C.® therapy is not recommended or designed for fistula effluent management or containment, but as an aid to wound healing in and around the fistula.The goal of therapy depends on whether the fistula being treated is considered acute or chronic.For acute fistula, the goal is to promote wound healing to enable closure of the acute enteric fistula.For chronic fistula, the enterocutaneous fistula is segregated from the surrounding or adjacent abdominal wound and v.A.C.® therapy is applied to the wound.The effluent from the fistula is diverted into another containment system.This allows time for the patient's overall health to stabilize and sufficient healing to take place to enable subsequent surgical repair.Fistula management: acute candidate selection enteric fistula, acute formation: no evidence of epithelial cells/growth on opening of fistula fistula opening must be easily visualized and accessed, npo (nothing by mouth), tpn (total parental nutrition), minimal to moderate amounts of effluent, effluent is thin to slightly viscous consistency.Chronic candidate selection: enteric fistula - non-surgical candidate.Chronic formation: evidence of epithelial cells/growth (stomatization).Mouth of fistula must be easily visualized and accessed.Npo (nothing by mouth).Tpn (total parental nutrition).
|
|
Search Alerts/Recalls
|
|
|