BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 8805150 · Received July 18, 2019

    Report

    Report Number
    9616066-2019-02004
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 26, 2019
    Report Date
    June 27, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORT OF A LEAK COMING FROM ABOVE THE ROLLER CLAMP OF THE TUBING WAS CONFIRMED. VISUAL INSPECTION OF THE SET OBSERVED SLIGHT FLUID LEAKAGE AT THE OUTLET OF THE ADAPTER TUBING AND PVC TUBING. FUNCTIONAL TESTING CONFIRMED THE LEAK. PRESSURE TESTING CONFIRMED THE LEAK. INSPECTION UNDER MAGNIFICATION OF THE ENGAGEMENT OF THE LEAK AREA OBSERVED THAT A SIDE OF THE TUBING'S OUTER DIAMETER WAS NOT ADHERED TO THE WALL OF THE ADAPTER TUBING. AN AREA OF THE TUBING DIRECTLY BELOW THE ADAPTER TUBING COMPONENT WAS CUT AND ITS OUTER DIAMETER WAS MEASURED AS 0.138 INCHES. THE MEASUREMENT WAS NOTED TO BE OUT OF SPECIFICATION PER ITS OUTER DIAMETER SPECIFICATION OF 0.145 ± 0.003 INCHES. ANOTHER AREA OF THE SAME TUBING, DIRECTLY ABOVE THE LOWER SMARTSITE COMPONENT, WAS CUT AND ITS OUTER DIAMETER WAS MEASURED AS 0.142 INCHES WHICH WAS WITHIN SPECIFICATION. THE ROOT CAUSE WAS IDENTIFIED AS A SUPPLIER ISSUE. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE ADMINISTERING AN ANTIBIOTIC AND PROGRAMMED AT AN UNSPECIFIED RATE THE CLINICIAN NOTICED A WET SPOT ON THE FLOOR AND UPON FURTHER INVESTIGATION NOTED A LEAK COMING FROM ABOVE THE ROLLER CLAMP OF THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 50 ML B BRAUN BAG, LOT: BA184090, EXP: 11/2, MEROPENEM INJECTION THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. SECTION A: ALTHOUGH REQUESTED, THE PATIENT¿S DEMOGRAPHICS WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ADMINISTERING AN ANTIBIOTIC AND PROGRAMMED AT AN UNSPECIFIED RATE THE CLINICIAN NOTICED A WET SPOT ON THE FLOOR AND UPON FURTHER INVESTIGATION NOTED A LEAK COMING FROM ABOVE THE ROLLER CLAMP OF THE TUBING. THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599052 ALARIS® PUMP MODULE ADMINISTRATION SET SET,ADMINSTRATION,INTRAVASCULAR FPA CAREFUSION 2420-0007 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1