BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6393750 · Received March 9, 2017

    Report

    Report Number
    9616066-2017-00422
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    February 22, 2017
    Report Date
    February 23, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 60 ML BD SYRINGE; 1000 ML EXACTAMIX BAXTER BAG. REF H938739, LOT: 1192207, EXP: 2016-11-04, THERAPY DATE: (B)(6) 2017. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF BALLOONING OF THE SILICONE SEGMENT WAS CONFIRMED. DURING INSPECTION IT WAS OBSERVED THAT THE SILICONE SEGMENT TUBING HAD A SLIGHT BULGE AND DISCOLORATION, AND WAS WEAKENED JUST BELOW THE UPPER FITMENT. FUNCTIONAL TESTING VIA GRAVITY FLOW AND PUMP INFUSION RESULTED IN THE FLUID FLOWING FREELY WITH NO BALLOONING OR OTHER ISSUES OBSERVED. BALLOONING WAS REPLICATED WHEN GIVING AN IV PUSH WITHOUT CLAMPING THE TUBING ABOVE THE INJECTION PORT. THE ROOT CAUSE OF THE BALLOONING WAS IDENTIFIED AS AN IV PUSH OR FLUSH BEING EXECUTED BELOW THE PUMP WITHOUT FIRST CLAMPING THE TUBING ABOVE THE INJECTION PORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE ADMINISTERING AN IV OF FAT EMULSION 20% 836 KCAL IN THE NICU, THERE WAS A BALLOON IN THE SILICONE PUMPING SEGMENT. THERE IS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 1

    CORRECTION: FAT EMULSION WAS 83.6 KCAL (NOT 836).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175925 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 2280-0000,20041E,20129E,20029E