MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C. FREEDOM NEGATIVE PRESSURE WOUND THERAPY SYSTEM; OMP

Model Number	WNDFRE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of the event: date of the event is unknown.Kci records indicate the "paient" was discontinued from v.A.C.Freedom¿ therapy on (b)(6) 2017 due to an amputation.Patient declined exchange of the device.Based on the information provided on (b)(6) 2017 that alleged the patient underwent an amputation due to the v.A.C.Freedom¿ therapy, kci could not determine that the alleged event was related to v.A.C.Freedom¿ therapy.The patient has a significant vascular surgical "histrory" with a known history of critical limb ischemia to the right leg, and as of 31-dec-2017, no additional information had been obtained.Therefore kci is reporting this event as it was unknown if v.A.C.Freedom¿ therapy caused or contributed to the amputation.Based on the additional information obtained on 21-nov-2018, the physician's nurse confirmed the patient's amputation was unrelated to v.A.C.Freedom¿ therapy.Kci has deemed this event not reportable based on the information received on 21-nov-2018.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.
Event or Problem Description
On (b)(6) 2017, the following information was reported to kci by the patient: the patient alleged his leg had to be amputated due to a faulty v.A.C.Freedom¿ negative pressure wound therapy system.Per review of the patient's medical records: v.A.C.Freedom¿ therapy system was applied to the patient's right lower leg.On (b)(6) 2017, the patient presented to the hospital with a painful, cold right foot.Patient was switched from coumadin to eliquis 1 month prior.Patient was placed on heparin bolus and heparin drip with a preoperative diagnosis of critical limb ischemia, right leg with thrombosed right femoral to posterior tibial artery bypass graft.The patient underwent a thrombectomy of a femoral to posterior tibial artery prosthetic graft with medial fasciotomies.V.A.C.Freedom¿ therapy was discontinued on (b)(6) 2017 for a surgical wound related procedure noted as right above the knee amputation.On 21-nov-2018, the following information was reported to kci by the physician's nurse: the patient's amputation was unrelated to activ.A.C.¿ therapy, and was a result of the patient's chronic vascular ischemia.On 10-oct-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 27-oct-2017, after the complaint, a service work order was created for exchange of the unit; however, the patient declined exchange of the device.The unit remains with the patient to date and is not available for evaluation in kci quality engineering.
Event or Problem Description
On (b)(4) 2018, the following information was reported to kci by the physician's nurse: the patient's amputation was unrelated to v.A.C.Freedom¿ therapy system, and was a result of the patient's chronic vascular ischemia.
Additional Manufacturer Narrative
Mdr-3009897021-2018-00105 submitted on 21-nov-2018 noted adverse event or product problem: on (b)(6) 2018, the following information was reported to kci by the physician's nurse: the patient's amputation was unrelated to activ.A.C.¿ therapy, and was a result of the patient's chronic vascular ischemia.Correction: on (b)(4) 2018, the following information was reported to kci by the physician's nurse: the patient's amputation was unrelated to v.A.C.Freedom¿ therapy, and was a result of the patient's chronic vascular ischemia.

• Brand Name: V.A.C. FREEDOM NEGATIVE PRESSURE WOUND THERAPY SYSTEM
• Common Device Name: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• MDR Report Key: 8096505
• Report Number: 3009897021-2018-00105
• Device Sequence Number: 2878997
• Product Code: OMP
• UDI-Device Identifier: 00849554006539
• UDI-Public: 0100849554006539
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K062227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WNDFRE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN 81 MG; ELOQUIS (DOSAGE UNKNOWN); LOVENOX 60MG/0.6 ML; LYRICA 50 MG; NIACIN 500MG; TOPROL-XL 50 MG DAILY; ASPIRIN 81 MG; ELOQUIS (DOSAGE UNKNOWN); LOVENOX 60MG/0.6 ML; LYRICA 50 MG; NIACIN 500MG; TOPROL-XL 50 MG DAILY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 81