MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM; OMP

Model Number WNDARM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteomyelitis (4533)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

Additional information for the v.A.C.® granufoam¿ dressing lot number 8384919v009: expiration date : 31-jul-2023; unique identifier (udi) # : (b)(4).Device manufacture date : 03-aug-2020 based on information provided, it cannot be determined that the alleged bone infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Kci has made multiple unsuccessful attempts to obtain additional clinical information.Device labeling, available in print and online, states: contraindications; do not place foam dressings of the v.A.C.® therapy system directly in contact with exposed blood vessels, anastomotic sites, organs or nerves.Warnings: protect vessels and organs: all exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of v.A.C.® therapy.Infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions, treatment goals.Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.Clinical considerations: in acute wounds with exposed bone or fractures, the v.A.C.® system may be used to help remove fluid and may remove infectious material secondary to the traumatic wound.Note: protect intact bone with a single layer of non-adherent material.

Event Description

On 05-nov-2020, the following information was reported to kci by the patient: on (b)(6) 2020, the patient went to the hospital due to an issue unrelated to v.A.C.® therapy and the physician allegedly identified the bone that had been exposed was infected.No additional information available.On 12-nov-2020, a device history record review for v.A.C.® granufoam¿ dressing lot number 8384919v009 was completed.All end release testing of the product and packaging met specifications.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.

Event Description

On 17-mar-2021, the a device evaluation was completed by kci quality engineering.On 03-sep-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) 2021, the device was tested per quality control procedure by kci service center, 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.

Manufacturer Narrative

Based on the additional information obtained regarding the device, kci's assessment remains the same; it cannot be determined that the alleged bone infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before and after patient placement.

Manufacturer Narrative

Mdr-3009897021-2020-01045 submitted on 04-dec-2020 noted the following: section e1 name and address: (b)(6).Section h10 additional manufacturer narrative: additional information for the v.A.C.® granufoam¿ dressing lot number 8384919v009: d4: expiration date: 31-jul-2023; unique identifier (udi) # : (b)(4).H4: device manufacture date: 03-aug-2020.Correction: section e1 name and address: (b)(6).Section h10 corrected data: additional information for the v.A.C.® granufoam¿ dressing lot number 8384919v009: d4: expiration date: 31-jul-2023; unique identifier (udi) # : (b)(4).H4: device manufacture date: 06-aug-2020.Based on the corrections, kci's assessment remains the same; it cannot be determined that the alleged bone infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.

• Brand Name: ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 10954221
• MDR Text Key: 219882709
• Report Number: 3009897021-2020-01045
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 416909
• Device Lot Number: 8384919V009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: - ALBUTEROL 0.5 MG; - ALBUTEROL 2.5 MG; - AMLODIPINE 5 MG; - ATORVASTATIN 20 MG; - ESCITALOPRAM OXALATE 20 MG; - GABAPENTIN 600 MG; - KETAMINE 10 MG; - LISINOPRIL 40 MG; - METHYLPREDNISOLONE 125 MG; - NALOXONE 4MG; - OMEPRZOLE 20 MG; - PROPOFOL 10 MG; - SUCCINYLCHOLINE 200 MG; - VANCOMYCIN 1000 MG
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 66 YR
• Patient Weight: 81