BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 2895034 · Received December 27, 2012

    Report

    Report Number
    3009897021-2012-00005
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    May 30, 2012
    Report Date
    October 26, 2012
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, KCI FIELD SERVICE TESTED THE DEVICE PER QUALITY CONTROL (QC) PROCEDURE AND DETERMINED THE UNIT MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT, WHICH INCLUDED THE PUMP AND ALARM FUNCTIONS. AS A RESULT OF THE ALLEGATION THAT THE UNIT WAS NOT FUNCTIONING PROPERLY, THE UNIT WAS REMOVED FROM THE HOSPITAL BY KCI AND REPLACED WITH ANOTHER UNIT. THE DEVICE WAS RETURNED TO KCI FOR EVALUATION. EVALUATION OF THE DEVICE IDENTIFIED A PROBLEM WITH A TRANSDUCER CONNECTION WHICH CAN POTENTIALLY CAUSE IMPAIRED PUMP FUNCTIONALITY, LIKELY CAUSED BY THE UNIT BEING DROPPED DURING USE. THE KCI EVALUATION ALSO DETERMINED THE IDENTIFIED TRANSDUCER PROBLEM WOULD NOT AFFECT THE OPERATION OF THE ALARM SYSTEM AND THAT IF THE PUMP WAS IMPAIRED, THE APPROPRIATE ALARM WOULD ALERT THE USER IMMEDIATELY. ON (B)(4) 2012, KCI FIELD SERVICE TESTED THE DEVICE PER QUALITY CONTROL (QC) PROCEDURE AND DETERMINED THE UNIT MET SPECIFICATIONS POST REPAIR.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE FOLLOWING INFORMATION WAS OBTAINED FROM THE NURSE: THE NURSE ALLEGED THE ACTIV.A.C. UNIT WAS NOT FUNCTIONING PROPERLY AS THE NURSE REPORTEDLY OBSERVED NO SUCTION AT THE DRESSING. ON (B)(6) 212, THE FOLLOWING INFORMATION WAS OBTAINED FROM THE NURSE: THE NURSE STATED THE ACTIV.A.C. UNIT DISPLAYED 150 MMHG (TARGET PRESSURE) BUT ALLEGED THE GRANUFOAM DRESSING WAS SOFT, WHICH SHE BELIEVED TO BE INDICATION NEGATIVE PRESSURE WAS NOT PRESENT AT THE DRESSING. UPON REMOVING THE PATIENT'S DRESSING, THE NURSE NOTED LESS THAN EXPECTED EXUDATES. THE NURSE SUCTIONED APPROXIMATELY 200 CC OF GREEN DRAINAGE FROM THE WOUND BED AND OBSERVED MACERATION AND A SLOUGH LIKE FILM COVERING THE WOUND BED. LABORATORY TESTING WAS PERFORMED AND THE PATIENT HAD ELEVATED C-REACTIVE PROTEIN AND WHIT BLOOD CELL COUNT LEVELS. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE PATIENT'S CONDITIONED RESOLVED. IT WAS REPORTED THAT THE WOUND HEALED COMPLETELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention