BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2040994 · Received March 25, 2011

    Report

    Report Number
    1625774-2011-00040
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    January 14, 2010
    Report Date
    February 24, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS TESTED PER QUALITY CONTROL (QC) PROCEDURES BY A KCI FIELD SERVICE EMPLOYEE ON (B)(6) 2010, PRIOR TO PLACEMENT WITH THE PATIENT ON (B)(6) 2010. THE UNIT PASSED QC CHECKS AND MET SPECIFICATIONS. THE UNIT REMAINED WITH THE PATIENT UNTIL (B)(6) 2010 WHEN THERAPY WAS DISCONTINUED. ON (B)(6) 2010, THE UNIT WAS RETURNED TO THE KCI SERVICE CENTER AND TESTED PER QC PROCEDURES BY A KCI FIELD SERVICE EMPLOYEE. THE UNIT PASSED QC CHECKS AND MET SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE REVIEWING MEDICAL DOCUMENTS: ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR NAUSEA AND VOMITING SECONDARY TO SMALL BOWEL OBSTRUCTION WHICH WERE UNRELATED TO V.A.C. THERAPY. ON (B)(6) 2010, THE PATIENT RECEIVED BLOOD ON VARIOUS OCCASIONS DUE TO HAVING A LOT OF SLOUGHING OFF OF THE WOUND WHICH WAS CAUSING THE WOUND TO BLEED. ON AN UNKNOWN DATE, THE PATIENT WAS CLINICALLY STABLE AND DISCHARGED HOME CLOSELY MONITORING THE BLOOD COUNT. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR NAUSEA AND VOMITING, ILEUS, URINARY TRACT INFECTION, ANEMIA, AND DIABETES WHICH WERE UNRELATED TO V.A.C. THERAPY. THE PATIENT HAD MULTIPLE BLOOD TRANSFUSIONS AS THE HEMOGLOBIN WAS 8 G SECONDARY TO THE BLOOD LOSS FROM THE WOUNDS. V.A.C. THERAPY WAS RESTARTED, THE PATIENT WAS CLINICALLY STABLE. IN (B)(6) 2010, THE PATIENT WAS DISCHARGED HOME ON V.A.C. THERAPY. ON (B)(6)R 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ANEMIA WITH A HEMOGLOBIN 5.8. THE PATIENT RECEIVED A BLOOD TRANSFUSION. IT WAS UNKNOWN WHAT THE ESTIMATED BLOOD LOSS WAS. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. WE ARE FILING THIS REPORT BECAUSE A POSSIBLE CONTRIBUTION DUE TO USE ERROR CANNOT BE ENTIRELY RULED OUT DUE TO LIMITED INFORMATION PROVIDED. THE TREATING SURGEON HAS DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM OMP KCI USA, INC. ACTIV.A.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R ZINC 50 MG DAILY| TRAMADOL 50 MG 3 TIMES A DAY| LEVOTHYROXINE 0.1 DAILY| PRILOSEC 20 MG DAILY| LYRICA 50 MG A DAY| MULTIVITAMINS 1 DAILY| IMIPENEM 400 MG 2 A DAY| GENTAMICIN OINT