BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 4960381 · Received August 3, 2015

    Report

    Report Number
    3009897021-2015-00056
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    June 22, 2015
    Report Date
    October 7, 2015
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED WORSENED FUNGAL INFECTION IS RELATED TO V.A.C.® THERAPY. THE NURSE CONFIRMED V.A.C.® THERAPY WAS APPLIED TO A PRE-EXISTING AND UNTREATED FUNGAL INFECTION. THIS REPORT IS BEING FILED DUE TO USER ERROR. 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.

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION OBTAINED REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED WORSENED FUNGAL INFECTION IS RELATED TO V.A.C.® THERAPY.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE NURSE: ON (B)(6) 2015, V.A.C.® THERAPY WAS PLACED ON HOLD. ON (B)(6) 2015, THE PATIENT WAS DISCONTINUED FROM V.A.C.® THERAPY. THE PATIENT ALLEGED EXPERIENCED "SEVERE CANDIDIASIS AND V.A.C. MADE SKIN WORSE." ON (B)(6) 2015, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: V.A.C.® THERAPY WAS APPLIED TO A PRE-EXISTING AND UNTREATED FUNGAL INFECTION. THE APPLICATION OF THE DRAPE TO THE FUNGAL INFECTION ALLEGEDLY CAUSED THE FUNGAL INFECTION TO WORSEN. THE WOUND WAS SUBSEQUENTLY TREATED WITH DIFLUCAN AND A TOPICAL ANTIFUNGAL POWDER. NO ADDITIONAL INFORMATION IS AVAILABLE. ON (B)(6) 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2015, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2015, KCI QUALITY ENGINEERING DETERMINED THAT AT LEAST THREE (3) UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE ACTIV.A.C.® DEVICE. THE LOCATION OF THE DEVICE REMAINS UNKNOWN AS OF THIS DATE; THEREFORE THE UNIT IS UNAVAILABLE FOR EVALUATION. THERE HAVE BEEN SEVERAL UNSUCCESSFUL ATTEMPTS MADE TO OBTAIN THE V.A.C.® DRESSING LOT NUMBER, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    ON OCT 01 2015, KCI QUALITY ENGINEERING COMPLETED A REVIEW OF THE DEVICE AND DETERMINED THE FOLLOWING: ON (B)(6) 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2015, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE 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. ON (B)(6) 2015, THE UNIT WAS SUBSEQUENTLY PLACED WITH A NEW PATIENT WITH NO REPORTED ISSUES DURING PLACEMENT. ON (B)(6) 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI QUALITY ENGINEERING. THE DEVICE EVALUATION WAS NOT ABLE TO CONFIRM THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504190 ACTIV.A.C.® THERAPY OMP OMP KCI USA, INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention