BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SETS - FLOW STOP

    MDR report key: 11743206 · Received April 29, 2021

    Report

    Report Number
    3012307300-2021-03567
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 11, 2023
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    15019517161953
    PMA / PMN Number
    K031361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. ONE SAMPLE WAS RECEIVED IN CONTAMINATED CONDITION INSIDE A PLASTIC BAG, WITHOUT ITS ORIGINAL PACKAGING. VISUAL INSPECTION WAS PERFORMED AT 12 TO 16 INCHES UNDER NORMAL CONDITIONS OF ILLUMINATION. DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THE SAMPLE DID NOT CONTAIN THE BLUE CLIP, ALSO OBSERVED THAT IT CONTAINED SOME LIQUID, THE SAMPLE WAS NOT COMPLETELY DECONTAMINATED. DURING THE FUNCTIONAL TESTING, WAS UNABLE TO FLUSH WITH SOLUTION SINCE THE LINE WAS BLOCKED, THEREFORE IT WAS CONFIRMED THE CUSTOMER COMPLAINT OF NON-DELIVERY MEDICATION. THE ROOT CAUSE WAS CAUSED BY AN INCORRECT SOLVENT DISPENSING SETTING AND AN EXCESSIVE AMOUNT OF SOLVENT. PRODUCTION PERSONNEL WERE NOTIFIED BY QUALITY ENGINEER AS AWARENESS FOR THE FAILURE MODE REPORTED BY CUSTOMER.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT THE WRITER PRESENTED TO THE CLIENT'S HOUSE TO CHANGE A CADD PUMP TUBING. THE TUBING CASSETTE WAS LOADED INTO THE CADD PUMP AND THE MED BAG SPIKED. PRIMING WAS INITIATED AND THE PUMP WAS SOUNDING LIKE IT WAS DRAWING FLUID, BUT NOTHING WAS COMING INTO THE TUBING. THE CASSETTE WAS REMOVED AND RELOADED, AND USER ENSURED THE SPIKE WAS FULLY INTO THE MED BAG. THE BATTERIES WERE CHANGED TO ENSURE ENOUGH POWER TO PULL THE MEDICATION THROUGH, HOWEVER, THERE WAS STILL NO FLUID BEING PULLED THROUGH THE TUBING. THE WRITE NOTIFIED THE GNH HPT PROGRAM, BUT NO SOLUTIONS WERE PROVIDED. THE WRITER PROVIDED THE PATIENT WITH NEW TUBING FROM A NEW LOT AND THEN PRIMED THE NEW BAG WITHOUT ANY INCIDENTS. THERE WAS NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641393 CADD ADMINISTRATION SETS - FLOW STOP INTRAVASCULAR ADMINISTRATION SET FPA ST PAUL 21-7346-24 4084036 15019517161953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown