BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    MDR report key: 10536346 · Received September 15, 2020

    Report

    Report Number
    3009897021-2020-00809
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    January 11, 2018
    Report Date
    October 1, 2020
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00849554005600
    PMA / PMN Number
    K201571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: MDR-3009897021-2020-00809-103414-ISS SUBMITTED ON 15-SEP-2020 DID NOT INCLUDE THE RESULSTS OF THE COMPLETED DEVICE EVALUATION AS WELL AS RATIONALE FOR DEEMING THIS EVENT NOT REPORTABLE. BASED ON THE INFORMATION PROVIDED ON 12-JAN-2018, KCI COULD NOT DETERMINE THAT THE ALLEGED HOSPITALIZATION AND INFECTION WERE RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. AS OF 11-FEB-2018, KCI DID NOT HAVE INFORMATION TO EXCLUDE THAT AN INFECTION WAS CONFIRMED REQUIRING ANTIBIOTIC TREATMENT. THE PATIENT HAD A RECENT MEDICAL HISTORY OF AN INTRA-ABDOMINIAL ABSCESS WITH SURGICAL INTERVENTION AND ANTIBIOTIC THERAPY ON (B)(6) 2017. BASED ON THE ADDITIONAL INFORMATION PROVIDED ON 21-AUG-2019, THE NURSE CONFIRMED THE HOSPITALIZATION AND INFECTION WERE UNRELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. KCI HAS DEEMED THIS EVENT NOT REPORTABLE BASED ON THE INFORMATION RECEIVED ON 21-AUG-2019. 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. 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. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A KINETIC CONCEPTS, INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    ON 15-DEC-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) 2018, THE DEVICE WAS PLACED WITH THE PATIENT. ON 29-JAN-2018, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI FIELD SERVICE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S FAMILY MEMBER: ON (B)(6) 2018, THE PATIENT WAS ADMITTED TO THE HOSPITAL ALLEGEDLY DUE TO AN ABDOMINAL ABSCESS, AND IS ANTICIPATED TO BE DISCHARGED DATE ON (B)(6) 2018. REVIEW OF RECORDS PROVIDED TO KCI ON 04-JAN-2018 NOTED THE FOLLOWING: ON (B)(6) 2017, THE POST-ANETHESIA CARE UNIT NURSE REPORTEDLY OBSERVED GREEN FOUL-SMELLING DRAINAGE POST-OPERATIVE LAPAROSCOPIC CONVERT TO OPEN APPENDECTOMY, OPEN DRAINAGE OF INTRAABDOMINAL ABSCESS, PERITONEAL LAVAGE PERFORMED ON (B)(6) 2017. ON (B)(6) 2018, THE PHYSICIAN NOTED THE PATIENT IS ON INTRAVENOUS ANTIBIOTICS. ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM HAS BEEN RUNNING WITHOUT INTERRUPTION. ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: HE WAS SATISFIED WITH THE MONITORING SERVICES. NO ADDITIONAL WAS AVAILABLE. ON (B)(6) 2019 THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE HOSPITALIZATION AND INFECTION WERE UNRELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001661 ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDARM 00849554005600

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O| R