BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1945869 · Received December 8, 2010

    Report

    Report Number
    1219702-2010-00005
    Event Type
    Other
    Date Received
    December 8, 2010
    Product Code
    FPA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SET WAS RECEIVED FOR EVAL ON (B)(4), 2010. THE SET WAS RECEIVED WITHOUT ANY OF THE ORIGINAL PACKAGING. IN ADDITION, UPON RECEIPT, THERE WAS RESIDUAL FLUID THROUGHOUT THE SET. UPON FURTHER INVESTIGATION, IT WAS CONFIRMED THAT A KINK WAS EVIDENT APPROXIMATELY 1" FROM THE FEMALE LUER FITTING ON THE PROXIMAL SIDE OF THE PT LINE. THE TUBING AT THE SITE OF THE KINK WAS FOLDED OVER AND FLATTENED WITH A CREASE, RETAINING A COMPRESSION SET WHEN UNFOLDED TO PARTIALLY OCCLUDE THE FLUID PATH. WE INSTALLED THIS SET INTO THE RAPID INFUSER AND PRIMED THE PT LINE. ONCE THE TUBING WAS STRAIGHTENED OUT, THE SYSTEM PRIMED WITHOUT INCIDENT. DURING OUR ROUTINE PACKAGING, THE PT LINE ASSEMBLY IS TAPED INTO A 4" - 5" DIAMETER COIL PRIOR TO ATTACHMENT BY LUER CONNECTION TO THE PRESSURE CHAMBER ASSEMBLY LINE. THE SET IS SECURED WITHIN A POLYSTYRENE TRAY WITH A THERMOFORMED PROTRUSION THAT IS INSERTED INTO THE MIDDLE OF THE COILED PT LINE. ONCE POUCHED, THE HEIGHT AND GEOMETRY OF THE TRAY PROTRUSION, THE DIAMETER OF THE COIL, AND THE CONFINING TOP POUCH PANEL, RESTRICTS THE MOVEMENT OF THE COILED TUBING, PREVENTING THE COIL FROM FLIPPING OVER AND POTENTIALLY KINKING OR TWISTING WITHIN THE POUCHED TRAY DURING SHIPPING AND HANDLING. EACH SET IS VISUALLY INSPECTED ONCE SECURED INTO ITS TRAY PRIOR TO POUCHING. SINCE THE SET WAS INSTALLED AND PRIMED IN ANTICIPATION OF USE BUT NOT ACTUALLY USED FOR INFUSION, IT IS NOT KNOWN HOW LONG THE SET WAS INSTALLED OR HOW THE PT LINE WAS SECURED TO PRESERVE FLUID PATH STERILITY AND SAFEGUARD AGAINST KINKING DURING THIS TIME PERIOD. WE BELIEVE THE END USER INADVERTENTLY INFLICTED A KINK INTO THE TUBING BY SUSPENDING THE PT LINE ASSEMBLY ABOVE THE PUMP UNIT TOWARDS THE IV POLE, CREATING A SEVERE ANGLE IN THE TUBING, FORCING THE TUBING WALLS TO KINK PRIOR TO PRIME. THERE IS NO EVIDENCE TO SUPPORT THAT THIS SET WAS NON-CONFORMING DUE TO DESIGN, MATERIALS, OR WORKMANSHIP. WE SHIPPED MORE THAN 40,000 SETS EACH YR AND HAVE NOT HAD A SIMILAR REPORT OF PT LINE ASSEMBLIES BEING FOLDED OVER AND KINKED FROM ANY OTHER HOSP.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FPA

    Patients

    Seq Age Sex Outcome Treatment
    1