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

Model Number WNDACT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged maceration is related to activ.A.C.¿ therapy system.Device labeling, available in print and online, states: ensuring dressing integrity: it is recommended that a clinician or patient (in the home) visually check the dressing every two hours to ensure that the foam is firm and collapsed in the wound bed while therapy is active if not: -identify air leaks by listening with a stethoscope or moving your hand around the edges of the dressing while applying light pressure.-if a leak source is identified, patch with additional drape to ensure seal integrity.-caution: use as few layers of drape as possible.Multiple layers of the v.A.C.® drape may decrease the moisture vapor transmission rate, which may increase the risk of maceration, especially in small wounds, lower extremities or load-bearing areas.Maintaining a seal: -for delicate periwound tissue or in areas that are difficult to dress, apply protective skin preparation and frame the wound with transparent film or hydrocolloid dressing or other appropriate barrier.-position the dressing tubing on flat surfaces and away from the perineal area, bony prominences or pressure areas.

Event Description

On (b)(6) 2017, the following information was reported to kci by the patient¿s family member: the surrounding area on the patient¿s tail bone wound was wet and allegedly macerated despite the activ.A.C.® therapy unit holding pressure.On dec 12 2017, the following information was reported to kci by the nurse: the patient underwent a debridement on (b)(6) 2017.Per review of kci records, on (b)(6) 2017, the wound care nurse assessed the patient¿s wound and noted ¿peripheral tissue edema¿ in the surrounding skin and the periwound appearance was noted as "normal for patient." the type of debridement or medical intervention was not documented in the treatment notes.

Manufacturer Narrative

Corrected date of event from (b)(6) 2017 to (b)(6) 2017.Based on information provided, it cannot be determined that the alleged maceration is related to activ.A.C.¿ therapy system.Device labeling, available in print and online, states: ensuring dressing integrity it is recommended that a clinician or patient (in the home) visually check the dressing every two hours to ensure that the foam is firm and collapsed in the wound bed while therapy is active if not: -identify air leaks by listening with a stethoscope or moving your hand around the edges of the dressing while applying light pressure.-if a leak source is identified, patch with additional drape to ensure seal integrity.-caution: use as few layers of drape as possible.Multiple layers of the v.A.C.® drape may decrease the moisture vapor transmission rate, which may increase the risk of maceration, especially in small wounds, lower extremities or load-bearing areas.Maintaining a seal -for delicate periwound tissue or in areas that are difficult to dress, apply protective skin preparation and frame the wound with transparent film or hydrocolloid dressing or other appropriate barrier.-position the dressing tubing on flat surfaces and away from the perineal area, bony prominences or pressure areas.

Event Description

On jan 23 2018, the following information was reported to kci by the patient¿s family member: the patient allegedly experienced maceration on (b)(6) 2017.The patient continued to receive v.A.C.® therapy.On nov 22 2017, the device with cord was tested per quality control (qc) procedure by kci field service, and the unit passed the qc checks and met specifications.On (b)(6) 2017, the device was placed with the patient.On dec 27 2017, the device was tested per qc procedure by kci quality engineering, and unit passed the qc checks and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.

Manufacturer Narrative

Mdr fu#1 sent on 24-jan-2018 concomitant medical products device available for evaluation was blank.Correction: checked 'yes' response and added 'returned to manufacturer' date 18-dec-2017.Based on this added dates.Kci's assessment remains the same; it cannot be determined that the alleged maceration is related to activ.A.C.¿ therapy system.

• Brand Name: ACTIV.A.C. THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX
• MDR Report Key: 7142162
• MDR Text Key: 95619959
• Report Number: 3009897021-2017-00122
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

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
• Device Operator: Health Professional
• Device Model Number: WNDACT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/28/2017; 12/28/2017
• Supplement Dates FDA Received: 01/24/2018; 11/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR