BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLO II

    MDR report key: 2858827 · Received November 8, 2012

    Report

    Report Number
    9616026-2012-00006
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 9, 2012
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    KOC
    PMA / PMN Number
    K082758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS BELIEVED THAT THE ACCIDENTAL DISLODGEMENT OF THE CATHETER WAS CAUSED BY AN IMPROPERLY APPLIED BLOOD WARMER AND AN IMPROPERLY APPLIED BLOOD LINE. IT APPEARS THE WEIGHT OF THE BLOOD WARMER SLEEVE CAUSED A TENSION TO THE BLOOD LINE RESULTING IN THE CATHETER DISLODGEMENT. IN THE INSTRUCTIONS FOR USE (OPERATOR'S MANUAL) FOR THE PRISMAFLO BLOOD WARMER IT STATED HOW TO SECURELY APPLY THE BLOOD WARMER IN ORDER TO PREVENT ANY UNWANTED SITUATIONS CAUSED BY THE BLOOD WARMER SLEEVE.

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A CRRT TREATMENT ON PRISMAFLEX CONTROL UNIT WITH A M100 FILTER SET AND A PRISMAFLO II BLOOD WARMER. THE SUTURED RIGHT IJ CATHETER WAS PULLED OUT DURING TREATMENT AND THE PATIENT LOST 152 ML OF BLOOD FROM THE EXTRACORPOREAL FILTER SET PLUS AN UNKNOWN AMOUNT OF BLOOD TO THE ENVIRONMENT. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS FROM THE BLOOD LOSS BUT HIS HGB DECREASED FROM 8.2 GM/DL TO 7.6 GM/DL AND HE RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS. THE NURSE MANAGER BELIEVES THE WEIGHT OF THE PRISMAFLO H WARMER SLEEVE ON THE RETURN LINE WAS SUFFICIENT ENOUGH TO PULL THE CATHETER FROM THE IJ. THE CRRT TREATMENT WAS RESUMED ON THE SAME PRISMAFLEX CONTROL UNIT ONCE THE CATHETER HAD BEEN REPLACED. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLO II BLOOD WARMER KOC STIHLER ELECTRONIC GMBH 113281

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other PRISMAFLEX M100 FILTER SET: LOT NO: NOT PROVIDED| PRISMAFLEX CONTROL UNIT: SERIAL NO: (B)(4)