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

Model Number WNDARM

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

Patient Problem Unspecified Infection (1930)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged infection is related to activ.A.C.¿ therapy.The patient has a history of osteomyelitis with a peripherally inserted central catheter placed for long-term antibiotic therapy.The patient has a foley catheter and colostomy bag which are potential infection prone sites.There have been several attempts made to gather additional information, but there has been no response.Device labeling, available in print and online, states: 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 and instillation therapy parameters (for the v.A.C.Instill® therapy system).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.Precautions: the v.A.C.® therapy system will not be effective in addressing complications associated with the following: ischemia to the incision or incision area; untreated or inadequately treated infection; inadequate hemostasis of the incision; cellulitis of the incision area.

Event Description

On 21-nov-2018, the following information was reported to kci by the patient's mother: on (b)(6) 2018, activ.A.C.¿ therapy was suspended due to deterioration of the patient's wound.A culture and sensitivity have been obtained and the results are pending.Per review of kci records: on (b)(6) 2018, activ.A.C.¿ therapy was placed on hold with a change of treatment and a urine culture was obtained.On (b)(6) 2018, the patient was admitted to the hospital for sepsis.No additional information available.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring is currently pending completion.

Manufacturer Narrative

Based on the additional information obtained regarding the device, kci's assessment remains the same; it cannot be determined that the alleged infection is related to activ.A.C.¿ therapy.

Event Description

On 04-oct-2018, the device was tested per quality control procedure by kci field service, and the unit passed the quality control checks and met specifications.On (b)(6) 2018, the device was placed with the patient.On 06-mar-2019, the device was tested per quality control procedure by kci quality engineering 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.

• Brand Name: ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX
• MDR Report Key: 8190466
• MDR Text Key: 131187757
• Report Number: 3009897021-2018-00120
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BACLOFEN AS NEEDED FOR SPASMS (DOSAGE UNKNOWN); FAMOTIDINE 30 MG TWICE A DAY; MEDICAL CANNABIS THREE TIMES A DAY; MIDODRINE HCL 2.5MG AT NIGHT; VESICARE 10MG DAILY; BACLOFEN AS NEEDED FOR SPASMS (DOSAGE UNKNOWN); FAMOTIDINE 30 MG TWICE A DAY; MEDICAL CANNABIS THREE TIMES A DAY; MIDODRINE HCL 2.5MG AT NIGHT; VESICARE 10MG DAILY
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR