BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT PLUM A+ INFUSION PUMP

    MDR report key: 613093 · Received March 23, 2004

    Report

    Report Number
    2921482-2004-00178
    Event Type
    Malfunction
    Date Received
    March 23, 2004
    Date of Event
    March 7, 2004
    Report Date
    March 7, 2004
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN UNDERDELIVERY DUE TO AN UNDETECTED OCCLUSION. THE PUMP WAS PROGRAMMED IN THE PIGGYBACK MODE TO DELIVER AN UNSPECIFIED SOLUTION AT AN UNSPECIFIED RATE ON LINE A, AND AN UNSPECIFIED CONCENTRATION OF POTASSIUM CHLORIDE AT AN UNSPECIFIED RATE ON LINE B. THE NURSE REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME, 10ML OF FLUID HAD INFUSED FROM LINE B WHILE THE PUMP DISPLAY INDICATED THAT 50ML HAD INFUSED. NO AUDIBLE ALARM WAS NOTED. THE NURSE REPORTED THEY SAW DROPS OF FLUID INFUSING ON LINE A; HOWEVER, THE PUMP DISPLAY INDICATED "LINE A DELAYED". IT WAS REPORTED THAT THE IV TUBING ON LINE B WAS LONGER THAN USUAL, CAUSING THE TUBING TO "KINKED OVER" THE PUMP RESULTING IN AN OCCLUSION. THE TUBING WAS UNKINKED WHICH ALLOWED LINE B TO INFUSE "FINE". THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PLUM A+ INFUSION PUMP INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other