BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 7142813 · Received December 22, 2017

    Report

    Report Number
    9616066-2017-01673
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 7, 2017
    Report Date
    December 8, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000ML BAXTER BAG NDC 0338-0117-04, LOT NUMBER Y243121, EXP FEB 19 LACTATED RINGER'S. THERAPY DATE (B)(6) 2017. THE CUSTOMER¿S REPORT OF A BULGE IN THE SILICONE SEGMENT WAS CONFIRMED. VISUAL INSPECTION SHOWED THAT THE SILICONE SEGMENT DIRECTLY BELOW THE UPPER FITMENT APPEARED TO HAVE BEEN PREVIOUSLY EXPANDED. FUNCTIONAL TESTING SHOWED NO UNEXPECTED BULGING ON THE SILICONE SEGMENT. PRESSURE TESTING RESULTED IN THE SILICONE SEGMENT DIRECTLY BELOW THE UPPER FITMENT STARTING TO BULGE. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT RETURNED FROM PACU WITH 1L IV FLUIDS INFUSING VIA GRAVITY THROUGH PRIMARY LINE. AT 2100 THE REGISTER NURSE NOTED A BULGE IN THE SILICONE SEGMENT. IT WAS REPORTED THE PACU NURSES AND ANESTHESIA DID NOT NOTICE ANYTHING UNUSUAL WITH THE IV TUBING AND UPON DISCHARGE FROM PACU TUBING WAS STILL PATENT AND INFUSING WITHOUT DIFFICULTY. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923270 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0500

    Patients

    Seq Age Sex Outcome Treatment
    1