BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABTHERA NEGATIVE PRESSURE THERAPY UNIT

    MDR report key: 5022228 · Received August 21, 2015

    Report

    Report Number
    3009897021-2015-00061
    Event Type
    Death
    Date Received
    August 21, 2015
    Date of Event
    June 9, 2015
    Report Date
    September 24, 2015
    Manufacturer
    KCI USA,INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED DEATH IS RELATED TO ABTHERA THERAPY. THERE IS NO REFERENCE IN THE PHYSICIAN'S DOCUMENTATION THAT ABTHERA NEGATIVE PRESSURE THERAPY UNIT WAS A CONTRIBUTING FACTOR IN THE PATIENT'S DEATH, AND THE PATIENT'S DEATH WAS MOST LIKELY A RESULT OF POST OPERATIVE COMPLICATIONS AND NOT ABTHERA NEGATIVE PRESSURE THERAPY.

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION PROVIDED IT CANNOT BE DETERMINED THAT THE ALLEGED DEATH IS RELATED TO ABTHERA THERAPY. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: IF A WOUND HAS BEEN PROGRESSING WELL FROM DRESSING CHANGE TO DRESSING CHANGE BUT THEN DETERIORATES RAPIDLY, CONSIDER THE FOLLOWING INTERVENTIONS AND, WHERE NECESSARY, SEEK THE GUIDANCE/EXPERTISE OF A SPECIALIST: CHECK THE THERAPY HOUR METER TO ENSURE THAT THE ACTUAL NUMBER OF THERAPY HOURS RECEIVED MATCHES THE NUMBER OF RECOMMENDED THERAPY HOURS (22 HOURS A DAY). IF THE NUMBER OF THERAPY HOURS IS LESS THAN 22 EACH DAY, FIND OUT WHY THERE IS A THERAPY DEFICIT AND REMEDY THE SITUATION. CLEAN WOUND MORE THOROUGHLY DURING DRESSING CHANGES. EVALUATE FOR SIGNS AND SYMPTOMS OF INFECTION AND, IF PRESENT, TREAT ACCORDINGLY. CHANGE DRESSING OFTEN, ENSURING THAT IT IS BEING CHANGED AT LEAST EVERY 48 HOURS. EXAMINE THE WOUND AND DEBRIDE AS NECESSARY. DEBRIDE THE WOUND EDGES IF THEY APPEAR NON-VIABLE OR ROLLED UNDER AS THIS MAY INHIBIT THE FORMATION OF GRANULATION TISSUE AND MIGRATION OF EPITHELIAL CELLS OVER AN ACCEPTABLE WOUND BASE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE FOLLOWING INFORMATION WAS REPORTED TO KCI (B)(4): ON (B)(6) 2015, THE PATIENT'S SON FOUND THE PATIENT COLLAPSED ON THE FLOOR AT HOME, AND THE PATIENT WAS TAKEN TO (B)(6) HOSPITAL. THE PATIENT WAS DIAGNOSED WITH A JUXTARENAL ABDOMINAL AORTIC ANEURYSM, UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR AND HAD ABTHERA NEGATIVE PRESSURE THERAPY UNIT PLACED. THE PATIENT RETURNED FROM THE OPERATING ROOM AND BECAME HYPOTENSIVE. THE PATIENT THEN EXPERIENCED CARDIAC ARREST, AND SUBSEQUENTLY EXPIRED. ADDITIONAL INFORMATION RECEIVED BY KCI (B)(4): THE WOUND CARE NURSE REPORTED THE CAUSE OF THE PATIENT'S CARDIAC ARREST IS UNDETERMINED. THERE IS NO REFERENCE IN THE PHYSICIAN'S DOCUMENTATION THAT ABTHERA NEGATIVE PRESSURE THERAPY UNIT WAS A CONTRIBUTING FACTOR IN THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    ON JUL 06 2015, THE FOLLOWING INFORMATION WAS REPORTED TO KCI (B)(4): THE PATIENT WAS UTILIZING AN ABTHERA NEGATIVE PRESSURE THERAPY UNIT FROM (B)(6) 2015 TO (B)(6) 2015 AT WHICH POINT THE PATIENT REPORTEDLY EXPIRED. ADDITIONAL INFORMATION RECEIVED BY KCI (B)(4): IT IS UNKNOWN HOW THE HEALTHCARE PRACTITIONER REGARDS THE ROLE OF THE KCI PRODUCT IN THE ALLEGED EVENT. THE CAREGIVER WAS TRAINED IN THE USE OF THE THERAPY AND DEVICE. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE BY THE KCI TERRITORY MANAGER TO OBTAIN ADDITIONAL CLINICAL INFORMATION RELATED TO THE CASE, INCLUDING THE CAUSE OF THE PATIENT'S DEMISE. NO ADDITIONAL CLINICAL INFORMATION IS AVAILABLE. ON APR 10 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI (B)(4) FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT. ON AUG 03 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI (B)(4) FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS POST PATIENT PLACEMENT. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554021 ABTHERA NEGATIVE PRESSURE THERAPY UNIT OMP OMP KCI USA,INC. WNDABT

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death