MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C. GRANUFOAM DRESSING; OMP

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Sinus Perforation (2277); Tissue Breakdown (2681); Foreign Body In Patient (2687)

Event Date 01/24/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the first date of onset is unknown.It was reported on the (b)(6) 2021 that the patient's wound was not healing and the patient was in the hospital.Thus, (b)(6) 2021 was utilized.Device evaluated by mfr: v.A.C.® granufoam¿ dressing lot number was not available and the dressing was not returned; therefore, a device history record review and a device evaluation could not be performed.Based on information provided, kci cannot determine when the foreign material alleged to be v.A.C.® granufoam¿ dressing was placed in the wound.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.Additionally, kci is unable to determine if the alleged wound worsening, slough/necrotic tissue, biofilm, infection, development of tunnels and drainage are related to the v.A.C.® granufoam¿ dressing.The patient has a history of infection and debridement prior to initiating v.A.C.® therapy.Per the patient, the hospital nurse and physician believe the v.A.C.® dressing was incorrectly done.V.A.C.® therapy was discontinued on 10-feb-2021.Therefore, the foreign material was left in the wound for over the manufacturer's recommendations.This event is being reported as a potential use error.Device labeling, available in print and online, states: warning: 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 alternate dressing, such as a wet to moist gauze, as approved during times of extreme need, by treating physician.Dressing changes: wounds being treated with the v.A.C.® therapy system should be monitored on a regular basis.In a monitored, non-infected wound, v.A.C.® dressings should be changed every 48-72 hours, but no less than 3 times a week, with frequency adjusted by the clinician as appropriate.Infected wounds must be monitored often and very closely.For these wounds, dressings may need to be changed more often than 48-72 hours; the dressing changing intervals should be based on a continuing evaluation of the wound condition and the patient's clinical presentation, rather than a fixed schedule.Foam placement: always use v.A.C.® dressings from sterile packages that have not been opened or damaged.Do not place any foam dressing into blind / unexplored tunnels.The v.A.C.® whitefoam¿ dressing may be more appropriate for use with explored tunnels.Do not force foam dressings into any area of the wound, as this may damage tissue, alter the delivery of negative pressure or hinder exudate and foam removal.Always count the total number of pieces of foam used in the wound.Document the foam quantity and dressing change date on the drape or foam quantity label if available, and in the patient's chart.Foam removal: v.A.C.® foam dressings are not bioabsorbable.Always count the total number of pieces of foam removed from the wound and ensure the same number of foam pieces are removed as were placed.Foam left in the wound for greater that the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing the foam from the wound or lead to infection or other adverse events.If dressing adheres to wound consider introducing sterile water or normal saline into the dressing, waiting 15 - 30 minutes, then gently removing the dressing from the wound.Regardless of treatment modality, disruption of the new granulation tissue during any dressing change may result in bleeding at the wound site.Minor bleeding may be observed and considered expected.However, patients with increased risk of bleeding, as described on page 8, have a potential for more serious bleeding from the wound site.As a precautionary step, consider using v.A.C.® whitefoam¿ dressings or nonadherent material underneath the v.A.C.® granufoam¿ dressings to help minimize the potential for bleeding at dressing removal in these patients.

Event Description

On 20-jan-2021, the following clinical notes were provided to kci by the treating provider: on (b)(6) 2021 office visit, it was noted that v.A.C.Whitefoam¿ dressing was discontinued and hydrofera blue comfortcel® packing [non-kci product] was started.On (b)(6) 2021, the following information was provided to kci by the patient: the activ.A.C.¿ therapy system allegedly experienced a technical issue.The patient reported that according to the physician, the top of the wound started to close but the inside or bottom of the wound is allegedly not healing.The patient is reportedly in the hospital.No additional information available.On (b)(6) 2021, the following information was provided to kci by the patient: the patient has a wound that is 1.5 cm in diameter with tunnels.At the hospital the wound exhibited a large amount of exudate.Therefore, the physician and hospital nurse reportedly believe the v.A.C.® dressing was incorrectly done by the home health nurse as there was a small amount previously.The patient's wound allegedly developed an infection and the patient was hospitalized.On 03-feb-2021, the following clinical notes were provided to kci by the treating provider: on (b)(6) 2021, the patient's wound was noted to exhibit foul odor after cleansing.The treating provider noted "stage iv pressure sore to left ischium with some worsening." the hydrofera blue comfortcel® packing [non-kci product] was discontinued and the home health was instructed to apply three pieces of v.A.C.Whitefoam¿ dressing to tunnels and one piece of v.A.C.® granufoam¿ dressing to fill the remainder of the wound.On 31-mar-2021, the following clinical notes were provided to kci by the case manager: on (b)(6) 2021, v.A.C.® therapy was placed on hold and mesalt® [non-kci product], changing daily with dakin's rinse every other day.The patient reported that over the past week there has been increased drainage and odor and is concerned about infection.The wound was noted to have copious amounts of foul smelling drainage.The physician referred the patient to a surgeon for further evaluation and treatment.On (b)(6) 2021, patient presented for a surgical consult for non-healing stage four pressure ulcer.The wound was explored and biofilm and slough were surgically debrided.The surgeon found and removed three pieces of foreign material alleged to be v.A.C.® dressing that has been shoved into deep crevices.Two pieces of foreign material were alleged to be v.A.C.Whitefoam¿ dressing and the third piece was alleged to be v.A.C.® granufoam¿ dressing.The foreign material was noted to be the likely source of the ongoing drainage and odor.The patient was placed on dakin's soaked gauze packing daily.V.A.C.® therapy was discontinued.On (b)(6) 2021, it was noted the patient continued to exhibit odor and the patient reported the visiting nurse removed another retained foreign material alleged to be v.A.C.® dressing.There has been no odor or fever since removal.The wound was explored and debrided with no evidence of foreign material.It was noted the tissue is healthy.The patient continued with mesalt® [non-kci product] and dakin's.On (b)(6) 2021, the primary surgeon noted the patient underwent a debridement and wash out of stage iv pressure ulcer.Upon inspection a tunnel was noted tracking towards the rectum.The tunnel was opened and some necrotic nonviable tissue was removed as well as a foreign material alleged to be v.A.C.Whitefoam¿ dressing.Laterally, another tunnel was noted and a foreign material alleged to be v.A.C.Whitefoam¿ dressing was removed.The areas were cleaned and debrided.It was noted, "significant undermining all the way down to the periosteum of the bone.Small bony fragments excised with rongeur.Two new separate tunnels identified each containing portions of old white sponge from previous vac dressing from months ago." on (b)(6) 2021, a new order for v.A.C.® therapy was placed.The v.A.C.Whitefoam¿ dressing and v.A.C.® granufoam¿ dressing lot numbers were not available, and the products were not returned; therefore, device history reviews and device evaluations could not be performed.Refer to mdr 3009897021-2021-00109 for the v.A.C.Whitefoam¿ dressing.

• Brand Name: V.A.C. GRANUFOAM DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 11816180
• MDR Text Key: 250335732
• Report Number: 3009897021-2021-00086
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN (LIPITOR); CEFUROXIME (CEFTIN); CHOLECALCIFEROL (VITAMIN D3); GABAPENTIN (NEURONTIN); IBUPROFEN (MOTRIN); ONDANSETRON (ZOFRAN); TEMAZEPAM (RESTORIL)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 70