BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 7970513 · Received October 16, 2018

    Report

    Report Number
    9616066-2018-01896
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    August 12, 2018
    Report Date
    September 5, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403230196
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEW IT WAS DETERMINED THAT THIS COMPLAINT IS NOT MDR REPORTABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ON THE CVICU, A TPN INFUSION ALARMED TWICE FOR AN "OCCLUSION, PATIENT SIDE". THE INFUSION WAS RESTARTED. THE THIRD TIME THE INFUSION ALARMED, THE INFUSION COULDN'T BE RESTARTED. THE PRODUCT WAS FOUND TO BE OCCLUDED, WHICH IMPEDED THE FLOW OF MILRINONE, "EPI", "DEX", PGE, TPN, AND LIPIDS. THE PRODUCT WAS CHANGED AND BLOOD RETURN WAS CHECKED. THE LINE CONTINUED TO BE SOMEWHAT "SLUGGISH" DUE TO POSITIONAL REASONS, BUT ITS USABILITY WAS RESTORED. THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    CONT¿D CONCOMITANT MEDICAL PRODUCT(S): 10 ML BD SYRINGE REFR306547, LOT NUMBER 8107773, EXP 2021-04-03, 0.9% SODIUM CHLORIDE; PICC. THE CUSTOMER¿S REPORT OF AN OCCLUSION WAS NOT CONFIRMED OR REPLICATED. VISUAL INSPECTION SHOWED NO ANOMALIES ON THE CONNECTOR. FUNCTIONAL TESTING RESULTED IN NO OCCLUSIONS, LEAKING, OR OTHER ISSUES. THE ROOT CAUSE OF THE REPORTED OCCLUSION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON THE CVICU, A TPN INFUSION ALARMED TWICE FOR AN "OCCLUSION, PATIENT SIDE". THE INFUSION WAS RESTARTED. THE THIRD TIME THE INFUSION ALARMED, THE INFUSION COULDN'T BE RESTARTED. THE PRODUCT WAS FOUND TO BE OCCLUDED, WHICH IMPEDED THE FLOW OF MILRINONE, "EPI", "DEX", PGE, TPN, AND LIPIDS. THE PRODUCT WAS CHANGED AND BLOOD RETURN WAS CHECKED. THE LINE CONTINUED TO BE SOMEWHAT "SLUGGISH" DUE TO POSITIONAL REASONS, BUT ITS USABILITY WAS RESTORED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810676 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ1000-07 10885403230196

    Patients

    Seq Age Sex Outcome Treatment
    1 (6)8100,(6)2432-0007,(2)8015,TD (B)(6) 2018